GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
FDA Recall Z-1989-2013 · Posted 2013-08-20
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAA
Date Initiated2013-05-02
Date Terminated2013-11-26
Product Quantity445 (421 US, 24 OUS)
Reason for Recall
GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems.
There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and
Firm Action
GE Healthcare "Urgent Medical Device Correction" letter dated May 1, 2013 to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter informed customers that GE Healthcare will correct all affected systems at no cost. A GE Healthcare service representative will contact you to arrange for this correction. For questions or concerns regarding this notification call: US 800-437-1171, Japan: 0120-055-919.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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