GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to su

FDA device recall Z-0012-2014 · posted 2013-10-17 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p

Action taken

GE Healthcare sent an "Urgent Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found. 1. If you observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. 2. If plastic grip is secure, but you observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always ON), you may continue to use the device with care. Use all safety precautions relative to application of the myelographic stop and the inhibit, table horizontal stop OFF. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 055 919 For other countries, please contact your local GE Healthcare Service Representative .

Root cause

Employee error

Status

Terminated

Product code

JAA

Quantity affected

810 (783 US, 27 OUS)

Distribution

Worldwide Distribution - USA (nationwided) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED AR

Date initiated

2013-08-30

Date posted

2013-10-17

Date terminated

2014-05-22

Location

Waukesha, WI

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