GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR7

FDA device recall Z-0983-2022 · posted 2022-04-21 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.

Action taken

The recalling firm, GE Healthcare, issued "URGENT MEDICAL DEVICE CORRECTION" letters to U.S. consignees dated 3/4/2022 via FedEx. Letters to OUS consignees began on 3/10/2022 via FedEx. The letters explained the issue, the affected product (all GE Healthcare MR Systems), and informed the consignee the device can continue to be used. Actions to be taken by the customer/user are: 1) If you are planning to de-install your GE Healthcare MR System, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative prior to any activities so that GE Healthcare can provide you with guidance for de-installation. 2) Complete and return the attached response form to Recall.60985@ge.com A response form was enclosed for completion and return to GE via email or scanning the QR code. The firm will provide a de-installation manual with specific instructions regarding safe de-installation of MR systems to all customers at no cost. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

LNH

Quantity affected

18,411 systems

Distribution

Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan

Date initiated

2022-03-04

Date posted

2022-04-21

Location

Waukesha, WI

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