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

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

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

Nucletron Plato External Beam Planning Radiation Therapy SoftwareV2.1.2 and MLC/Shape Software Module V2.3 Recall #Z-038-0. REASON Coordinates for radiation beam used in therapy are mislabeled in software. CODE Plato RTS software version V2.1.2 used with software module MLC/Shape version V2.3. MANUFACTURER Nucletron BV, The Netherlands. RECALLED BY Nucletron Corporation, Columbia, Maryland, by letter and customer...Read More

11 systems. Acqplan Radiation Therapy Planning System. A software option for computed tomography scanners. An incorrect calculation of ISO/N dosage may result when changing parameters. Z-1236-9Read More

7-July-99 Olympus. Class III field correction. EPROM Version 3.00 Software for the Olympus EVIS CV-140 Video System Center. The device has a malfunction due to incorrect coding of the software which can cause the software to overwrite the patient ID number with any comments that are entered by the user.. Z-1227-9IVDRead More

30-June-99 C30-June-99 Kavo Dental 7 units. Class III. AC powered dental drilling device. Software error may cause unit to shutdown prior to reaching preset torque limit. Z-1215-9Read More

28-June-99 Quinton Instruments 11 review stations and 7 Sequence NIS stations. Class II.Under certain specific circumstances,sequences of a single plane study, may overlap sequences of bi-plane study when viewing both on the Angiocomm Single Sequence Review Station or the Single Sequence Network Interface Station (NIS). Z-1116/1119-9Read More

6/22/99 Bayer Corporation 3767 units. Class III Technicon SETpoint Chemistry Calibrator. During review of the value assignment procedure it was learned that the operator manually entered intercept corrected SETpoint values into an Excel spreadsheet rather than letting the spreadsheet calculate the corrections from the true SETpoint. The values that were entered were incorrect and, therefore,...Read More

6/14/99 Cardiopulmonary Corporation 59 units. Class II Venturi Ventilator with hard drive. User interface software will not load when unit is first powered on. Z-1039-9Read More

Defense Blood Standard System (DBSS), Blood Bank Software. Recall #B-1094-9. REASON Blood bank computer software does not identify all potential duplicate donor records. CODE Software Versions 3.00 and 3.01. MANUFACTURER Electronic Data Systems (EDS), Herndon, Virginia. RECALLED BY U.S. Department of Defense (DBSS)Composite Health Care System 2, Falls Church, Virginia, by E-mail on June 9...Read More

Boehringer Mannheim/Hitachi 917 Disk System, a clinical chemistryanalyzer system. Recall #Z-1040-9. REASON The barcode reader can read the wrong sample barcode, mismatch the test results, and report them under the wrong sample. CODE All versions of the disk system software with an updated barcode reader. This includes the system with Serial No. 9715-05 and all...Read More

5/21/99 VIA Medical Corporation 59 units. Class II VIA Low Volume Mode (LVM) Monitor. The devices has a software problem that can cause the monitor, under unusual circumstances, to display and print a chemistry value from a previous sampling instead of the blood chemistry value from the current sampling. Z-1041-9.Read More

5/18/99 Cardiopulmonary Corporation 1 unit. Class II Venturi Ventilator Software revision C. Software error may cause ventilator to deliver more than set tidal volume. Z-803-9Read More

Abbott Alcyon Analyzers with Alcyon System Software Version 1.6.Recall #Z-267-0. REASON The device may give incorrect tests results or reference ranges when printing the “Complete Report (header)”, “Incomplete Report (DRAFT)”, and the “Control Results printout.” CODE List #4E73-04. MANUFACTURER Abbott Laboratories, Inc., Irving, Texas. RECALLED BY Manufacturer, by telephone on May 18 and 19, 1999,...Read More

4/30/99 Bayer Diagnostics 1000 units. Class II ADVIA 120 Hematology System When running the ADVIA 120 system in the manual mode using the Host Query feature and the timeout is set to 13 seconds, it is possible for the system to report incorrect patient results. The supplemental labeling instructions section of the product labeling instructs...Read More

4/16/99 Class II Colleague 3 Volumetric Infusion Pump (Triple Channel). Baxter Healthcare 6,992 units. A software communication error occurs predominately when all three channels are in use, causing an alarm codition that will stop the function of all of the channels in use. The pump will alarm appropriately, alerting the user of the failure state....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

REASON Defective software could result in failure to give warning. CODE Version V1.4 and all previous versions of the software. MANUFACTURER Marquette Medical Systems, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone and letter sent on April 8, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Canada, France, Australia, Italy, Sweden. QUANTITY 368 units were distributed.Read More

Donor Management Information System, Version 1.2. Recall #B-602-9. REASON Y2K defect in the computer software incorrectly calculates the end date of a temporary deferral to be 1900 instead of 2000, and removes the deferral from the database. CODE 11 systems were distributed. MANUFACTURER Information Data Management, Rosemont, Illinois. RECALLED BY Manufacturer, by telephone on January...Read More

4/6/99 Class II Phillips Medical 1086 units. Integris family of x-ray controls and generators (fluoroscopy,, urology, cardiology). The defect occurs when the system is driven to maximum EER and the source to image receptor distance (SID) is moved toa shorter distance while continuing to make exposures. In this manner of operation, the output may exceed...Read More

3/29/99 Digisonics Class II OBLink software releases prior to 9.0 39 units. Y2K sofvtware error may produce an incorrect estimated delivery date (EDD). Z-1056-9.Read More

Eagle 3000 Floorloader Steam Sterilizer. Recall #Z-936-9. REASON There is an error in the control system software, which causes the chamber temperatures to exceed the upper limit. CODE Various serial numbers. MANUFACTURER Steris Corporation, Erie Pennsylvania. RECALLED BY Steris Corporation, Mentor, Ohio, by Customer Notifications on March 10, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada,...Read More

Philips Medical Sonodiagnost 800, intended for endovaginal biopsy for various gynecologic and obstetric procedures including follicular retrieval, endometrial biopsy, and fluid aspiration of any type in a potentially pregnant patient. Recall #Z-772-9. REASON Software used with Transducer EV7014 incorrectly indicates track of the biopsy needle. CODE All SD800’s with Software versions 2.1. and 2.1.1 used...Read More

3/5/99 Class II Hewlett Packard 145 units. Software used with transducer EV7014 incorrectly indicates track of biospy needle. Z-772-9Read More