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/Docs/SCPRed/SoftwareCPR-Newsletter052601.PDF
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/Docs/SCPRed/CDRHInfo-collection-reqmtsExcerpts.PDF
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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...
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http://www.accessdata.fda.gov/cdrh_docs/pdf/k010605.pdf
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/Docs/UKDefenseSoftwareSafetyStd00-55Part1.pdf
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/Docs/UKDefenseSoftwareSafetyStd00-55Part2.pdf
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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:...
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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,...
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/Docs/FDA-DeviceLabelingandManualsGuidance.pdf
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Company: Stough Enterprises Date: 4/18/01 Product: Blood & Plasma Product Category: Biologics/Blood Failure to appropriately determine the suitability of donors prior to the collection and distribution of the blood product because on January 30, 2001, a donor screener was observed reading the questions too quickly for the donor to respond prior to the screener entering...
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Company: AvidcareWL Date: 4/17/01 Product: In home Asthma Monitoring System …”Under a United States Federal law, the Federal Food, Drug and Cosmetic Act (the Act), these products are considered to be medical devices because they are used to diagnose or treat a medical condition or to affect the structure or function of the body. Home...
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Company: Cardiomedics Inc.Date: 4/13/01 Product: Counter pulsation devices No procedures for the development of software used to control devices. The software used for the operation of the CardiAssist CounterPulsation system was not properly validated. Problems with this software have been identified and corrective measures have been undertaken to replace this software version. Electro Static Discharge...
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Company: GE Medical Systems Inc. SADate: 4/10/01 Product: Full Field Digital Mammography Device Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing...
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Company: Neuro Control Corp. Date: 4/9/01 Product: NeuroControl Freehand System Also, at the time of the meeting your firm was using a procedure entitled, “Return Inspection Procedure for the Freehand Backup Implantable Components”. As we stated in our meeting with your firm, this procedure appears to involve electronic record. The recent FDA inspection revealed that...
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Company: Zeus Scientific Inc.Date: 3/27/01 Product: IVD test kits In addition to the above,your firm failed to validate the electronic documentation system used to record corrective action requests (CARs) prior to implementation. The electronic record requires electronic signature,for which there is no timestamp on the record. Also, you failed to certify to the FDA that...
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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...
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/Docs/Lilly483Response031801.pdf
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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....
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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...
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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...
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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:...
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483Company: Eli Lilly & Company City and Sate: Indianapolis, IN FDA District: Detroit, MI Dates of Inspection: 1/29-2/9, 21, 22, 23/01 18. SOP #001-001757 “Process Control System Security” is used as a global document to describe the guidelines for maintaining the security of the process control systems and related documents for Parentaeral Products Operations. However,...
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The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software: “i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem: Stewart Crumpler Office...
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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,...
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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,...
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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,...
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Company: Aventis Behring L.L.C.Date: 1/22/01 Product: Biological products Product category: Human Drugs Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that changes were not implemented to restrict access and entry...
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Last fall John Taylor, Director, FDA Office of Enforcement took over as leader of the agency’s Part 11 Compliance Committee. As of January 2001: 1. The draft guidances on Validation and Glossary of Terms are now in formal review at the agency. This does not mean they are close to final. 2. FDA has suspended...
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In 2000, a coalition of trade associations was formed to provide input to FDA regarding interpretation of Part 11. This unusual effort across industries has been undertaken due to the global nature of the rule and the cost and impact of compliance to the rule depending on interpretation. The initial group of six national trade...
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Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the _____ System and _____ network computer software programs for materials and data management functions. The _____ performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...
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Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the yyyy System and zzzz network computer software programs for materials and data management functions. The —- performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...
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Earlier this month FDA recognized UL 1998 for software. It followed up in the second half of the month by publishing new supplmentary information sheets for all recognized software standards that explains the recognition and how each could be used to reduce software documentation in submissions. Subscribers to SoftwareCPR.com can login, go to the Library...
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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...
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Societa Italiana Mediciniali Scandicci 12/6/00 APIs …The computer systems used to control and/or monitor production, reconcile raw materials, assign batch numbers, and control solvents, have not been validated. The validation of the computer system used to control the … process is incomplete…. We have also reviewed your November 3, 2000 written response to the FDA-483…...
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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,...
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SOL Pharmaceuticals – Active pharmaceutical ingredients – Human Drugs For example, values in at least two … areas were altered. Altered values were written under computer generated values on the … and used in the potency calculations. Review of the electronic data confirmed the incorrect values, which were part of your submission to DMF Your...
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As of 11/15/00 FDA CDRH formally recognizes “ANSI/UL 1998 Software in Programmable Components” for software submissions. Details of the recognition have not yet been posted by FDA as of 11/19/00 but the original intent was for this to be the first software standard to be recognized for devices with software of a MAJOR level of...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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