7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic

FDA device recall Z-1430-2011 · 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: 176
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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Related 510(k) clearances

Record	Firm	Date
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM (K032795)	Ge Medical Systems, LLC	2003-10-08