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Terminated

Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.

FDA Recall Z-2584-2018 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-05-24
Date Terminated2019-02-08
Product Quantity42 units total

Reason for Recall

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

Firm Action

GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.

Root Cause

Component change control

Distribution Pattern

Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131576OPTIMA CT660Ge Medical Systems, LLC · 2013-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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