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U.S. Department of Health and Human Services

Class 2 Device Recall AIR Technology Anterior Array

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 Class 2 Device Recall AIR Technology Anterior Arraysee related information
Date Initiated by FirmMarch 19, 2019
Create DateOctober 07, 2019
Recall Status1 Terminated 3 on March 30, 2020
Recall NumberZ-0062-2020
Recall Event ID 83814
510(K)NumberK172695 
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
ProductAIR 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.
Code Information 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     
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionThe 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
Quantity in Commerce22 units
DistributionWorldwide Distribution - US Nationwide in the states of AZ, CA, MS, NY, WI, DE, and countries of France, Germany, Japan, Netherlands, Spain, Sweden,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = MOS
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