2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for gene

FDA device recall Z-1425-2011 · posted 2011-02-24 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety. If the gradient cables are inadvertently swapped while servicing the gradients, and the Service Engineer does not perform the geometry check as required in the service procedure, images m

Action taken

On November 9, 2010, the firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated November 5, 2010 to all Consignees/Customers. The letter described the product, problem and action to be taken by the firm. GE instructed the customers to contact their local GEHC support Engineer, if they have any questions about the image orientation, or the procedures for geometry checks on thier system. Additionally, a GE Healthcare representative will install a device, which will reduce the potiential for the gradient cables to be swapped. Contact your local GEHC Support Engineer if you have any questions concerning this notification or phone: 262-548-2731.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LNH

Quantity affected

1

Distribution

Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACE

Date initiated

2010-11-09

Date posted

2011-02-24

Date terminated

2012-07-03

Location

Waukesha, WI

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