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

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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

Individual Monitoring Systems -Electroencephalogry 2/11/00 “…Failure to validate computer software for its intended use. For example, your firm has not validated the software used to perform sensitivity calibration of the ActiTrac device. “ SoftwareCPR keywords: production software validation.Read More

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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

The Device Quality System Regulation (GMP) explicitly requires signatures in the following places: The sections of the regulation which specifically require signatures are: · Sec. 820.30 Design controls.c & d · Sec. 820.40 Document controls a & b · Sec. 820.75 Process validation a · Sec. 820.80 Receiving, in-process, and finished device acceptance d&e. ·...Read More

The Drug GMPs explicitly require signatures in the following places: 211.186 master prod & control recs 211.182 Equipment cleaning & use logs 211.188 batch prod & control recs 211.194 laboratory recs (perform & review) Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where...Read More

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Compnay: SOL PharmaceuticalsProduct: Active pharmaceutical ingredients Poduct Category: Human Drugs Date: 1/21/200 In addition, our investigative team found it impossible to trace computer generated …because they were not date stamped.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

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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

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The Medical Device and Diagnositc Industry periodical occassionally prints software articles oriented to Medical Device Manufacturers. To see their index of these articles by year, view the following link: MDDI Software ArticlesRead 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

Diasorin, Saluggia Italy 23-Dec-99 production/QC software validation for reagents”8. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [21 CFR 820.70(g)] in that the Gamma Counter Data Transfer Validation, dated March 31. 1999. did not...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

7. Failure to maintain complete and adequate written SOPS that reflect current bloodbank operations as requiredby21 CFR 606.100(b) and 606.60. For example, with respect to the computer system in use, there were no SOPS available for security procedures for unauthorized access, review of the system and correction of errors, and control of changes in hardware...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

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3d) Standard operating procedure Routine Release of Crossmatched Blood and Blood Products has not been updated to include computter operations utilizing xxx Blood Bank and Blood Donor Computer System versionyyyy. Specifically, the procedure does not include what type of second verification of information entered into the computer should be performed when blood products are released...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

Status of FDA permission requirements for Blood Bank establishment use of electronic crossmatch as of November 18, 1999: Because 21 CFR 606.151 requires a serologic crossmatch those hospitals (all hospitals) who wish to use the electronic crossmatch must apply for a variance to 21 CFR 606.151 (as allowed by 21 CFR 640.120) to gain written...Read More

Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75....Read More

Published November 1999 in “Pharmaceutical Tecnology” was the the article “Using New Techniques for Reducing System Validation Time and Cost”. This article described an approach used in an Eli Lilly drug plant for validation of PLCs and an Intellution system where many similar but slightly different programs and pieces of manufacturing equipment were used. Its...Read More

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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

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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

Mountain View Blood Bank 10/5/99 The _____ Procedure, Revision Date 10-26-94, required donors who test repeatedly reactive for HTLV- 1/2, HIV, HBsAg and HCV to be permanent y deferred and the donors notified. Employees lacked adequate training because they were not following this procedure [21 CFR 606.20(b)]. The donor deferral files were not adequate to...Read More

Failure to review and evaluate all complaints and maintain a record of the reason no investigation was made and the name of the individual responsible for the decision not to investigate; failure to maintain records that demonstrate that each batch, lot, or unit of device meets in-process or finished device specifications; failure to validate and...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

The New England Biomedical Discussion Group held a half-day seminar on Risk Management. Alan Kusinitz of SoftwareCPR gave a presentation on Software Risk Management. The newsletter summary of the seminar is at the link provided: Intro to Risk Management ArticleRead More

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6. Failure of the DMR (device master record) to include device specifications including appropriate drawings, composition, formulation, component specifications and software specifications, as required by 21 CFR 820.181(a). For example:Read More

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CRS-USA LASIK 8/18/99 Clinical Trial Software Validation There was no verification that the data submitted by the clinical investigators matched source data at the site. The only data verification was performed by the computer data service, xxxx and involved scrutinizing the data for such errors as out-of-range data, field entry omissions, exam dates out-of-range, and...Read More

South Florida Blood Bank 8/12/99 The inspection revealed that complete and accurate donor deferral records are not being maintained. A deferred donor that tested repeatedly reactive HBsAg on February 12, 1998 (Unit #2251435) was improperly re-entered for donation on August 12, 1998 without a neutralization test being performed. This donor should have remained in deferral....Read 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