—#176414

Product

AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.

FDA product code: MOS — Coil, Magnetic Resonance, Specialty
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K172695
Affected lot / code info: Catalogue # UDI # Mfg. Lot or Serial # 5746694 0100840682138611111812132100339 339 5746694 0100840682138611111809122100324 324 5746694 0100840682138611111805312100311 311 5746694 0100840682138611111901022100340 340 5746694 0100840682138611111811302100334 334 5746694 0100840682138611111808302100323 323 5746694 0100840682138611111809132100325 325 5746694 0100840682138611111809192100326 326 5746694 0100840682138611111801292100303 303 5746694 0100840682138611111801232100301 301 5746694 0100840682138611111808152100319 319 5746694 0100840682138611111808272100320 320 5746694 0100840682138611111812042100335 335 5746694 0100840682138611111806072100313 313 5746694 0100840682138611111807182100315 315 5746694 0100840682138611111802122100307 307 5746694 0100840682138611111811092100328 328 5746694 0100840682138611111812072100337 337 5746694 0100840682138611111807232100316 316 5746695 0100840682138611111808282100321 321 5746695 0100840682138611111808292100322 322 5746696 0100840682138611111812132100338 338

Why it was recalled

The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.

Root cause (FDA determination)

Device Design

Action the firm took

The firm hand delivered the notices beginning on 03/19/2019. The notices described the separation of the outer seam and requested that the consignee check each coil component for tears or damage, and to discontinue use of product if product is suspected of not being in good condition. The affected products will be replaced. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,

Timeline

Recall initiated: 2019-03-19
Terminated: 2020-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.