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Terminated

GE Discovery MR950 MRI system

FDA Recall Z-1395-2015 · Posted 2015-05-01

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeIWE
Date Initiated2014-10-24
Date Terminated2015-05-06
Product Quantity5 units (2 in US)

Reason for Recall

The alignment lasers are missing the labels required by radiation safety regulations.

Firm Action

GE Planned action(s) to repair defect or to bring product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 5 units consists of the following: 1. New labels will be mailed to all purchasers, with instructions to apply the label in the appropriate location on the unit, or a GE field engineer will be sent to each user site to complete the correction. 2. All mailings and service calls will be made at no cost to the purchaser. 3. The corrections will be completed by August 1, 2015. If you have any questions, please contact your local Service Representative or call 1 (800) 437-1171.

Root Cause

Error in labeling

Distribution Pattern

US Distribution to the state of CA., and Internationally to Italy and Japan.

Official Source

View FDA Recall →

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

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