June 19, 2019
Company: GE Healthcare, LLC Date of Enforcement Report: 6/19/2019 Class II PRODUCT GE Centricity PACS-IW versions 3.6.0 through SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x Recall Number: Z-1781-2019 REASON There is a potential that one or more image series (i.e., all images within an image...
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Company: Philips North America, LLC Date of Enforcement Report: 6/19/2019 Class III PRODUCT Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the...
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Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report: 6/19/2019 Class II PRODUCT Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. Recall Number: Z-1769-2019 REASON An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration...
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Company: Conformis, Inc. Date of Enforcement Report: 6/19/2019 Class II PRODUCT Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Recall Number: Z-1775-2019 Recall Number: Z-1776-2019 REASON Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. RECALLING...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 6/19/2019 Class II PRODUCT InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim...
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Company: One Lambda Inc Date of Enforcement Report: 6/19/2019 Class II PRODUCT UniMatch Plus Software (Catalog ID 790111 and A10286, Version 6.0) when used in association with CHR_005_201807v1.uch Recall Number: B-0675-2019 REASON The UniMatch Plus Software, containing incorrect allele specificity information, which may result in an ambiguous result or a mistyping, was distributed. RECALLING FIRM/MANUFACTURER...
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Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to by Sep 25, 2019 if possible!

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