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

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

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

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: 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: 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: 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

Class: IIPRODUCT Fenwal Autopheresis-C Plasmapheresis System, Models A-200, A-201, and A- 401. Recall #B-860-0. REASON The Autopheresis-C Plasmapheresis instruments with version 6.0 software may proceed to “Saline Rinse” without displaying the Remove Plasma prompt. CODE Product Code Numbers: 4R4550, 4R4560, 4R4561, R4R4585 MANUFACTURER Baxter Healthcare Corporation, Largo, Florida. SOFTWARE DEVELOPER Baxter Healthcare Corporation, Round Lake,...Read More

PRODUCTComponents and Distribution Information System (CDIS) Stand Alone Blood Bank Software. Recall #B-1094-0. REASON Blood bank software contains a defect that results in not all products produced from a donation receiving the special donation properties that are applicable to donation. CODE All versions up to and including version 1.1.1. MANUFACTURER Information Data Management, Inc., Rosemont,...Read More

PRODUCT Version 6A and prior versions of software for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems, a patient monitoring system designed to collect and transmit ECG and other physiological data from ambulatory patients, without the patient being physically connected to a display device. Recall #Z-774-0. REASON Due to a software defect, there could be...Read More

PRODUCT Architect i 2000 System. Recall #Z-906-0. REASON System allows running of samples while the automatic flushing/cleaning occurs. CODE All units, all software versions. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter on April 25, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Puerto Rico, Korea, Mexico, Canada,...Read More

PRODUCT Roche Hitachi 914 Chemistry Analyzer, used for diagnostic testing for routine and specialty chemistry analytes. Recall #Z-613-0. REASON There is a potential for mismatch of sample identification information and results on this version of software. CODE Catalog number 914000. All units with software version 3.0. MANFACTURER/SOFTWARE SITE Roche Diagnostic Corporation, Indianapolis, Indiana. RECALLED BY...Read More

PRODUCT Roche/Hitachi 917 Disk System Chemistry Analyzer, Catalog #917000. Recall #Z-612-0. REASON There is a potential for mismatch of sample identification information and results on all versions of software. CODE All units/software versions. MANFACTURER/SOFTWARE SITE/SOFTWARE SITE: Hitachi Instruments Division, Ibari-ken, 312 Japan. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated March 17, 2000....Read More

PRODUCT a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and medication. Recall #Z-913/914-0. REASON Glucose values greater...Read More

PRODUCT Fixer Image Scan Editing Utility, Version 3.0, intended to allow the user to remove spurious image slices from a scan. Recall #Z-784-0. REASON Fixer 3.0 may provide inconsistent results if a file is changed and saved twice in the same session. CODE Fixer Software Utility Version 3.0 MANUFACTURER Radionics, Inc., Burlington, Massachusetts. RECALLED BY...Read More

PRODUCT MINICAP XP Workstations, using Baseline 8.5 software, for Computed Tomography SPECT studies with gamma cameras. Recall #Z-515-0. REASON During 360 degree SPECT, the resulting image will appear flipped left to right. CODE All Marconi MINICAP XP workstations using the Baseline 8.5 software. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY Manufacturer, by...Read More

PRODUCT SoftBank LIS or Softbank Laboratory Information System. Recall #B-692-0. REASON There is no way of assuring that ADT-Interface transactions will always include correct patient data. CODE All versions installed in computer systems. MANFACTURER Soft Computer Consultants, Palm Harbor, Florida. RECALLED BY Manufacturer, by letters dated February 28, 2000, followed by visit. Firm-initiated field correction...Read More

PRODUCT Magnetom 42 SP Magnetic Resonance Imaging System with Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body: a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A); b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall...Read More

All Architect I System Processing Modules with Software Versions1.0 and 1.01. Recall #Z-910-9. REASON The device may report incorrect results for diluted samples; and/or when used with the Laboratory Information System or Host Information Systems, the system may incorrectly associate test results with patient ID or incorrectly associate control results with patient records. CODE List...Read More

2/24/00 Class II PRODUCT Aeroset Assay Disks, V3.0 Conventional Units, used as a software diskette to upgrade the Aeroset System, which is a clinical chemistry analyzer, used for in-vitro diagnostic tests. Recall #Z-488-0. REASON The disks are improperly duplicated and contain software that will install System International (SI) units, rather than conventional units as labeled....Read More

2/21/00 Class II PRODUCT Aeroset Analyzer, used for in-vitro diagnostic tests. Recall #Z-489-0. REASON Under certain washing conditions, software error causes erratic urine creatinine results. CODE All Codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated February 21, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 176 analyzers were...Read More

REASON Failure to correctly re-calculate drug dosage using saved Drug Dosage Data. PRODUCT Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000, SC9000XL, intended for adult, pediatric, and neonatal monitoring of clinical environment. Recall #Z-399/401-0. CODE Infinity Modular Monitors: SC7000, SC8000, SC9000, SC9000XL with software versions VEO, VEO.1 or VEO.2 MANUFACTURER Siemens Medical Systems, Inc., Danvers,...Read More

REASON Potential for incorrect Pediatric Reports–A software problem. PRODUCT a) 2-way MainFrame Interface Software Version 22.20; b) Pediatric Therapy Guide Version 4.10. Recall #Z-405/406-0. CODE Part Numbers: 9800-2666 and 9800-0630; Catalog Numbers: B1018-15 and B1011-30. MANUFACTURER Dade Microscan Inc., West Sacramento, California. RECALLED BY Manufacturer, by letter on February 4, 2000. Firm-initiated field correction ongoing....Read More

REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter. PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall #Z-412-0. CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D. MANUFACTURER...Read More

1/13/00 Class II PRODUCT Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i. Recall #Z- 462/463-0. REASON Software program errors cause incorrect association between patient and the patient results. CODE All codes. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by letter dated January 13, 2000....Read More

1/8/00 Class III recall PRODUCT Software for Pulmonary Function Testing System: a) BreezePF v3.8 Software, Catalog No. 147536-003; b) BreezePF v3.8A Software, Catalog No. 147570-003. Recall #Z-450/451-0. REASON An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1/FVC ratio is selected for diagnostic reporting. The problem only...Read More

REASON Software error in Vitros ECi Immunodignostic system. PRODUCT Vitros Immunodiagnostic System, a random access immunodiagnostic analyzer for quantitative and qualitative determination of analytes in human specimens. Recall #Z-360-0. CODE Catalog #8633893, Serial #30000054-30001120. MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letters dated December 28, 1999, and January 13, 2000, and...Read More

REASON Software may incorrectly link previous assay results to a different patient ID. PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology. Recall #Z-358/359-0. CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01...Read More

PRODUCT AcQ Plan, 3-D Radiation Therapy Treatment Planning System (software), a software option for the Computed Tomography (CT) Scanners. Recall #Z-300-0. REASON Software anomaly causes the isocenter shift to be labeled incorrectly. CODE All units using the AcQPlan Therapy Planning software version 4.04 are affected. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY...Read More

PRODUCT Mini-Med MMT-508 Insulin Pump, indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall #Z-288-0. REASON The pump’s software has an error in which the current basal rate profile indicated on the pump display, was a rate programmed for earlier in...Read More

100 copies. Pato Brachytherapy Treatment Planning System Version 13.2 and higher. Software Implementation Error. Z-039-0/Read More

REASON The software validation of version 4.01R1 a software anomaly was found that affected the proper function of a print option. PRODUCT Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG software feature used in conjunction with the Critikon Observer Central Station on which is installed. There are 12 models or catalog numbers of...Read More

PRODUCT Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions a) 4/1; b) 4.4, implanted autonomic nerve stimulator for he treatment of epilepsy. REASON The label insert sheets were printed with the incorrect lot number. CODE Lot numbers a) 23952C; b) 26023C, 27137C, 27735C. Recall #Z-570/571-0. MANFACTURER Cyberonics, Inc., Inc., Houston, Texas. RECALLED BY Manufacturer, by...Read More

IMED Gemini PC-4 Volumetric Infusion Pump and Controller withVersion 1.85 Software: a) PC-4 Infusion Pump, Model 1340, 110 volts; b) PC-4 Infusion Pump, Model 1341, 220 volts. Recall #Z-174/175-0. REASON Due to a software modification, the devices will stop infusing and alarm if the processors receive conflicting or confusing messages. CODE All pumps that carry...Read More

223 units. 740 ventilator system and ventilator 760 system. Any Ventilator will revision J. software. Software can cause under or over delivery of oxygen. Z-170/171-0Read More