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Terminated

GE Optional Laser Centering Device X-ray generator.

FDA Recall Z-2320-2015 · Posted 2015-08-13

Recalling FirmGE Inspection Technologies, LP
Recall StatusTerminated
Product CodeRER
Date Initiated2014-11-10
Date Terminated2017-02-01
Product Quantity25

Reason for Recall

GE has identified a potential failure to comply with 21 C.F.R. 1040.10 and 21 C.F.R. 1010.2 for the alignment laser centering device.

Firm Action

GE's Planned Action for repair: 1. Replacement compliant laser centering devices will be shipped to purchasers, with prepaid shipping envelopes for purchasers to return the noncompliant units to GE. 2.All mailings will be made at no cost to the purchaser; and 3.The corrections will be completed by November 1, 2015 Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. For further questions please call (717) 447-1278.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.

Official Source

View FDA Recall →

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

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