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Terminated

GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.

FDA Recall Z-0989-2007 · Posted 2007-07-12

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-07-06
Date Terminated2013-02-01
Product Quantity22 units

Reason for Recall

The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

Firm Action

Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, France, Singapore, Sweden, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041931OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATIONGe Oec Medical Systems, Inc. · 2004-08-26

Official Source

View FDA Recall →

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

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