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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Healthcare, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0062-2020

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