Company: Marconi Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0057-2, Marconi MX8000 Computed Tomography X-ray Codes: All Marconi MX8000 CT Scanners running with Version 2.0 sofware. REASON: A software anomaly in ver 2.0 software may result in improper patient diagnosis. MANUFACTURER/RECALLING FIRM: Marconi Medical Systems, Inc., Highland Heights,...Read More

Company: Nihon Kohden, IncDate of Enforcement Report: 10/24/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0177-2/Z-0178-2, Procyon Bedside Monitors, Models BSM-4104A and BSM- 4114A. Codes: Models BSM-4104A and BSM-4114A Bedside Monitors. REASON: Software causes infusion rate 2.2 times proper rate. MANUFACTURER/RECALLING FIRM: Nihon Kohden, Inc., CA RECALLED BY: Recalling firm by telephone and letter on...Read More

Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Codes: MECC Backplane “2104938 REV C” —...Read More

Company: TegimentaDate of Enforcement Report: 10/17/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model 400, Catalog number 1045199. All serial numbers of analyzers lower than 38-2606. Serial numbers of 38-2606 or higher have already been updated with software revision upgrade 4. REASON: If the operator fails to...Read More

Company: Bayer CorporationDate of Enforcement Report: 10/10/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-1223-1, Software versions AE through AL (except AI) for the Bayer Advia Centaur Automated Chemiluminescence Immunoassay System. The affected software was distributed as a component of the Advia Centaur Automated Chemiluminescence Immunoassay system. Codes: Software versions AE through AL, except version...Read More

Company: SIEMENS MEDICAL SYSTEMS, INCDate of Enforcement Report: 9/19/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1106-1 – Z-1108-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Codes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 through...Read More

Company: WELCH ALLYN PROTOCOL, INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1049-1 Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01,4.03.02, 4.03.03, 4.03.04, and 4.03.05 when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05 REASON: Incorrect Visual Display MANUFACTURER/RECALLING FIRM: WELCH ALLYN PROTOCOL,...Read More

Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software CODES: Model OVIO03, Version 2.2 REASON: Leak of piston pump valve introduces air bubbles. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, Inc., Newark, DE, by letter. FIRM INITIATED...Read More

Company: SIEMENS MEDICAL SYSTEMS, INC.Date of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1105-1/Z-1107-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine proceduresCodes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 thru 2016 b) Model...Read More

Company: SANGUIN INTL., INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1048-1 Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 The software Medusa 2000 is an interface link to the Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]....Read More

Company: GE Medical Systems, Information TechnologiesDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1078-1 Clinical Information Center Software. The brand name was Marquette when the product was initially distributed. CODES: All devices with V.2 and later revisions of the software. REASON: Device can improperly restart resulting in no alarms or information...Read More

Compnay: Siemens Medical Systems, IncDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0851-1 ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203. Codes: All E.CAM gamma cameras with the Profile option with ICON-P workstations...Read More

Company: Applicare Medical ImagingDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0857-1/Z-0858-1 RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes: RadWorks...Read More

Company: Siemens Medical Systems, Inc.Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0769-1 – Z-0771-1 E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 CODES: a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and...Read More

Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software version 2.2. REASON: Leak of piston pump valve introduces air bubbles. CODES: Model OVIO03 Version 2.2 MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, INC., Newark, DE., by letter...Read More

Company: DADE BEHRING, INCDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1 REASON: Incorrect low results for a number of patient samples. CODE: Version 5.1 MANUFACTURER: DADE BEHRING, INC., NEWARK, DE RECALLED BY: Manufacturer, by letter 4/9/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...Read More

Company: AGILENT TECHNOLGIES Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0948-01/Z-0949-01 Agilent Technologies (formerly Hewlett Packard Co.) (A)Anesthesia Monitoring Systems, M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242...Read More

Company: Medica Corp.Date of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0951-1 EasyBlood Gas Analyzer. REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg. CODES: EasyBlood Gas Analyzers with Software version below M4.20. MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA. RECALLED BY: Manufacturer, by fax on 8/15/00....Read More

Company: Baxter Healthcare CorporationDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: B-1332-1, Amicus Separator Apheresis Instrument with software version 2.50 REASON: Blood collection device may return an inappropriate volume of plasma to a donor during an apheresis procedure. MANUFACTURER: Baxter Healthcare Corporation, Largo, FL RECALLED BY: Baxter Healthcare Corp., Round Lake,...Read More

DATE RECALL INITIATED< br> August 24, 2001 PRODUCT / LOT NUMBER / EXPIRATION DATE: FlexiLab Blood Bank and Blood Donor Software, Software versions 5.2, 5.23, and 5.3 MANUFACTURER: Sunquest Information Systems, Inc. Tucson, AZ REASON: A software defect has the potential to result in blood components/derivates reaching inventory “Available Inventory Status” without a product testing...Read More

Company: DADE BEHRING MARBURGDate of Enforcement Repor: 8/22/01t Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1, Behring Coagulation System (BCS) software version 2.2 REASON: Leak of piston pump valve introduces air bubbles MANUFACTURER: DADE BEHRING MARBURG, Germany RECALLED BY: DADE BEHRING, INC., GLASGOW, DE, by letter to the three accounts informing them of the problem...Read More

Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0733-1, FlexiLab Laboratory Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic Pathology Lab Access Transcription Workstation. REASON: Software glitch MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ RECALLED BY: A temporary procedural workaround was communicated to all...Read More

Company: DADE BEHRING, INC.Date of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software version 5.1 REASON: Incorrect low results for a number of patient samples MANUFACTURER/RECALLING FIRM: DADE BEHRING, INC., Newark, DE RECALLED BY: Manufacturer, by letter on 4/9/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...Read More

Company: ALARIS MEDICAL SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-748-1, Model PC-1 A one channel, general purpose, infusion pump, 220V CE Marked, International only (Software version 8.12 and 8.13) REASON: Motor stall MANUFACTURER/RECALLING FIRM: ALARIS MEDICAL SYSTEMS, INC., San Diego, CA RECALLED BY: International mailings are being coordinated...Read More

Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0735-1, FlexiLab Laboratory Information System, Version 5.23 REASON: Software anomaly MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., Tucson AZ RECALLED BY: A temporary procedural workaround was communicated to all affected customers in Product Safety Notice PSN-01-L18, June 8, 2001. FIRM INITIATED...Read More

Company: SONOSITE, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-868-1, Sonosite 180 – portable, software controlled ultrasound system intended for use with a variety of transducers to perform a variety of scans and measurements/calculations for the abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code: Sonosite units with the following software...Read More

Date Recall Initiated:July 20, 2001 Product: Solar 9500 Physiological ECG Monitor Use: To monitor patient vital signs including blood pressure, pulse, temperature, cardiac output, respiration, and anesthetic gas concentrations during surgery. This product is intended for use under the direct supervision of a licensed health care practitioner. Reason for Recall: Incorrect computer chips were installed...Read More

Company: Toshiba America Medical Systems, Inc.Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0690-1, Impax Technology Inc. DDS Intended use is as Diagnostic Image Display Software Model/catalog number: DS3000, CS5000, XA3000 REASON: Wrong image presents to radiologist upon database query. MANUFACTURER/RECALLING FIRM: Toshiba America Medical Systems, Inc., Tustin, CA RECALL BY:...Read More

Company:Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE Z-0691-1 through Z-0693-1 Software used on the Computerized Tomography Fluoroscopy CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners REASON: X-ray generation without operator command using unusual program sequence. MANUFACTURER/RECALLING FIRM:...Read More

Date of Enforcement Report: 7/11/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0629-1, Multi-Therapy Ambulatory Infusion Pumps sold under the following labels a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump) and 606000-40I (International) b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832 REASON: Potential overinfusion in the Auto-Ramp mode...Read More

RECALL NUMBER, PRODUCT AND CODE:Company: Community Blood Center of Greater Kansas City Date of Enforcement Report: 7/11/01 Class: II B-1457-1, Red Blood Cells Units L04250, L02615, M84346, T52350, T033222,T031302, T028101, T025140, T012049, T007397 B-1458-1, Platelets, Pheresis, Units T038725, T035305, T034495 B-1459-1, Platelets Units T031302, T012049, T007397 B-1460-1, Fresh Frozen Plasma Units L04250 (divided into 4...Read More

Company: Electronic Data Systems (EDS)Enforcement Report Date: 6/13/01 Class: II PRODUCT: Defense Blood Standard System, Blood Bank Computer Software, – In use at 79 military facilities. Recall # B-897-1. REASON: Due to a defect in computer software, expired blood products that were returned, and units that were received at out of spec temperatures, were not...Read More

Company: Analogic CorportationDate: 6/13/01 Class: II PRODUCT: a) Philips Tomoscan M. Recall # Z-550-1. b) Philips Tomoscan EG. Recall # Z-551-1. c) Philips Tomoscan EG. Recall # Z-552-1. REASON: The diagnostic x-ray devices fail to conform to design specifications relating to the accomplishment of their intended purpose. CODE: a) Philips Tomoscan M; b) Philips Tomoscan...Read More

Recall of Amicus Separator Operating with Version 2.50 Software REASON: Baxter Healthcare Corporation is recalling Amicus Separators operating with version 2.50 software after discovering that the device may return an inappropriate volume of plasma to a donor during an apheresis procedure. This occurrence has been observed during single needle procedures using Amicus Separators operating with...Read More

Company: Cardiomedics, Inc. Date of Enforcement Report: 5/30/01 Class: II PRODUCT: CardiAssist External Counter Pulsation (ECP)System. Recall #Z-573-1. REASON: The screen on the unit containing software version 1.4.3 intermittently locks up. Unexpected shutdown; deletion of use for cardiogenic shock. CODES: n/a MANUFACTURER: Cardiomedics, Inc., Irvine, CA. RECALLED BY: Manufacturer, by facsimile, dated April 4, 2001,...Read More

Company: Instrumentation Laboratory Co. Date of Enforcement Report: 5/30/01 Class: III PRODUCT: ACL Futura Coagulation Analyzers. Recall #Z-577-1. REASON: There is a software error that may cause index file and record information to be mismatched. CODES: All Serial Numbers with software version below V3.4. MANUFACTURER: Instrumentation Laboratory Co., Lexington, MA. RECALLED BY: Manufacturer, by letters,...Read More

Company: Mediware Information Systems, Inc.Date: 5/29/01 REASON: The expiration date of a manufactured product may be mistakenly extended, without displaying a warning to the user, when entered under certain specific conditions. DATE RECALL INITIATED: May 29, 2001 PRODUCT / VERSIONS Hemocare Blood Bank Data Management System Software Software versions 5.1, 5.2, 5.2a, 5.2b for use...Read More

Date of Enforcement Reporl: May 9,2001Class: II PRODUCT: ISS 2001 X-Ray Imaging System. Recall # Z-246-1. REASON: The systems fail to conform to design specifications relating to the emission of electronic product radiation. MANUFACTURER: Fischer Imaging Corporation,Denver, Colorado. RECALLED BY: Manufacturer, to supply new version (1.4) of software by May 1, 2002. Firm- initiated recall...Read More

Company: Philips Medical Systems Nederland B.V.Date of Enforcement Report: 4/25/01 Date of Recall: February, 2001 Class: II PRODUCT: EasyVision CT/MR Workstation with software release 1.x AND 2.x. Recall #Z-0495-1. REASON: If Ct scans made on different dates, the Image sets are merged into one exam. CODES: EasyVision CT/MR Workstation with release RI.X and release. MANUFACTURER:...Read More

Company: Philips Medical System Nederland B.VDate of Enforcement Report: 4/25/01 Date of Recall: 5/1/97 Class: II PRODUCT: Gyroscan T5 Magnetic Resonance Diagnostic Device NT. Recall #Z-0500-1. REASON: If computer shuts down the system patient nurse call alarm is not activated. CODES: All Gyroscans delivered from factory since October 1996LOT NUMBER (S)OR S/N(S) Serial Numbers 182,...Read More

Company: Ortho-Clinical Diagnostics, Inc.Date of Enforcement Report: 3/21/01 Date of recall letter: 6/26/00 Class: II PRODUCT: a) Vitros 250 and Vitros 250 AT Chemistry Systems Software version below 7.0.; Recall #Z-386-1. b) Vitros 950 and Vitros 950AT Chemistry Systems with software version below 3.07. Recall #Z-387-1. REASON: The Bilirubin (Unconjugated Bilirubin) results may be reported...Read More

Company: Sunquest Information Systems, Inc.Date of Enforcement Report: 3/7/01 Date of Recall: 1/15/01 Class: II PRODUCT: Flexilab Laboratory Information System (not for use in blood banks). Recall #Z-0369-1. REASON: Software anomaly allows misprint of patient information. CODE: Flexilab version 5.23 with RBR module. MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ. RECALLED BY: Manufacturer, by fax...Read More

Company: Ortho-Clinical Diagnostics, Inc.Date of Enforcement Report: 3/7/01 Date of recall: 6/28/00 Class: III PRODUCT: Vitros 250 Chemistry Systems with Software Versions 6.x (6.0,6.01, 6.02, etc). Recall #Z-249-1. REASON: Test results may be mis-reported as 0.0 for any analyte including CK-MB, acetaminophen, iron, lithium, and salicylate. CODES: Catalog #8132086. Vitros 250 Chemistry System serial numbers...Read More

Company: Olympus America, Inc.Date of Enforecement Report: 3/7/01 Date of Recall: 10/1/99 Class: III PRODUCT: Integrated Endosurgery EndoALPHA Software Version 3.01. Recall #Z-381-1. REASON: The device software version 3.01 prevented the control unit from retaining the user-programmer coagulation setting. CODE: Catalog #UCES (Control Unit for Endosurgery), software version 3.01. MANUFACTURER: Olympus America, Inc., Melville, NY....Read More

Date of enforcement report: 2/28/01Date of recall: 9/12/00 Company: Escreen Inc. Class: II PRODUCT: EScreen System, which collectively includes the eCUP, the eREADER optical imaging technology, and the eCUP data analysis software, for use in drug abuse testing. Recall #Z-205-1. REASON: Distributed without 510(k) clearance. CODE: All. MANUFACTURER: EScreen Inc., Overland Park, KS. RECALLED BY:...Read More

Company: DPC Cirrus, Inc., Date of Enforcement report: 2/7/01 Date of recall: 11/3/00 Class: III PRODUCT: Immulite 2000 Automated Immunoassay Analyzer Software Versions 1.6 and 1.61. Recall No. Z-183-1. REASON: Software code is incorrect for manual dilutions in the Batch Tests by Rack, which could cause incorrect calculation of results. CODE: None. MANUFACTURER: DPC Cirrus,...Read More

Company: Raichem Date of enforcement report: 1/31/01 Date of recall: 12/20/00 PRODUCT: Roche Creatinine Mira, Catalog No.3033414. Recall #Z-071-1. REASON: Package insert, contained in the kit, was printed with an incorrect reagent volume for COBAS MIRA analyzers using software Version 8735. CODE: Lot No. A12071, Exp. September 2002. MANUFACTURER: Raichem, division of Hemagen, San Diego,...Read More

Date of Recall 4/4/00 Date of Enforcement Report: 01/24/01 PRODUCT: LTV Series Ventilator. Recall Nos. Z-154/156-1. REASON: Failure of the LTV series ventilator software to detect a disconnect. CODE: Model No. LTV 1000; Model No. LTV 950; Model No. LTV 900. MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA. RECALLED BY: Manufacturer, by letter on April 4,...Read More

PRODUCTFastTake Compact Blood Glucose Monitoring System, used to quantitatively measure glucose (sugar) levels in whole blood taken during home-care use, under the following trade names: One Touch FastTake Compact Blood Glucose Monitoring System (in the U.S. and Canada); PocketScan Compact Blood Glucose Monitoring System (in the United Kingdom); EuroFlash Compact Blood Glucose Monitoring System (in...Read More

PRODUCT Escort E300 Series Patient Monitor, intended use is as an electrocardiograph and respiration monitor. Recall #Z-030-1. REASON It is possible for the High Breath Rate Alarm to function incorrectly under certain conditions. CODE Serial numbers are non-sequential (there are gaps), are four digits long and include: 1001 to 4086. MANUFACTURER Medical Data Electronics, Arleta,...Read More