Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Precision 500D, Legacy, RFX, and SFX X-ray imaging systems, manufactured by GE Healthcare. The affected part numbers are 2258627, 2305472, 2305495, 2404103, 2403791, 2403791-3, 2403791-32, 2403791-40, 46-262751G2, 46-262751G4, 46-262751G5, 46-262751G6, 46-262751G7, and 46-262751G8.

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 position, and causing the system to strike the patient. No injuries have been reported to date related to this issue.

The manufacturer advises users to inspect power assist handle for either of the two conditions listed below, and immediately contact local GE Healthcare Service Representative if any issue is found.

• If users observe that the power assist handle plastic grip is loose relative to the mount, discontinue use.
• If plastic grip is secure, but users observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always ON), users 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.

Furthermore, GE Healthcare will correct all affected systems.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON316301

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 2 October 2013