AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: (1) QBY0002025 QBY0002027 QBY0001994 QBY0001993 QBY0002001 QBY0002006 QBY0002008 QBY0002002 QBY0002003 QBY0002007 QBY0002010 QBY0002004 QBY0002036 QBY0002040 QBY0002042 QBY0002044 QBY0002039 QBY0002035 QBY0002034 QBY0002033 QBY0002026 QBY0002041 QBY0002037 QBY0002051 QBY0002052 QBY0002055 QBY0002054 QBY0002058 QBY0002056 QBY0002301 QBY0002059 QBY0002311 QBY0002352 QBY0002429 QBY0002478 QBY0002529 QBY0002628 QBY0002695 QBY0002696 QBY0002698 QBY0002710 QBY0002711 QBY0002740 QBY0002742 QBY0002741 QBY0002778 QBY0002795 QBY0002820 QBY0002818 QBY0002811 QBY0002834 QBY0002827 QBY0002828 QBY0002829 QBY0002830 QBY0002831 QBY0002836 QBY0002838 QBY0002843 QBY0002844 QBY0002859 QBY0002860 QBY0002926 QBY0002927 QBY0002936 QBY0002909 QBY0002935 QBY0002937 QBY0002938 QBY0003040 QBY0003162 QBY0003185 QBY0003215 QBY0003216 QBY0003135 QBY0003137 QBY0003141 (2) Lot/Serial Number QBY0002279 QBY0002294 QBY0002295 QBY0002293 QBY0002305 QBY0002284 QBY0002280 QBY0002299 QBY0002298 QBY0002296 QBY0002278 QBY0002290 QBY0002287 QBY0002281 QBY0002289 QBY0002277 QBY0002285 QBY0002378 QBY0002377 QBY0002384 QBY0002380 QBY0002386 QBY0002387 QBY0002388 QBY0002394 QBY0002390 QBY0002392 QBY0002391 QBY0002396 QBY0002398 QBY0002395 QBY0002399 QBY0002472 QBY0002482 QBY0002483 QBY0002484 QBY0002485 QBY0002518 QBY0002521 QBY0002522 QBY0002524 QBY0002525 QBY0002528 QBY0002535 QBY0002536 QBY0002537 QBY0002538 QBY0002539 QBY0002540 QBY0002541 QBY0002544 QBY0002550 QBY0002551 QBY0002561 QBY0002562 QBY0002567 QBY0002568 QBY0002577 QBY0002578 QBY0002579 QBY0002580 QBY0002614 QBY0002617 QBY0002620 QBY0002621 QBY0002667 QBY0002666 QBY0002681 QBY0002685 QBY0002686 QBY0002688 QBY0002689 QBY0002691 QBY0002692 QBY0002693 QBY0002705 QBY0002706 QBY0002707 QBY0002708 QBY0002760 QBY0002835 QBY0002761 QBY0002888 QBY0002891 QBY0002892 QBY0002959 QBY0003220 QBY0003221 QBY0003225 QBY0003227 QBY0003228 QBY0003229 QBY0003230 QBY0003231 QBY0003311 QBY0003321; (2) QBY0002306 QBY0002616
  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:
Angiodynamics Inc. (Navilyst Medical Inc.)
Reason for Recall:
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0

Product Codes/Lot Numbers:

Serial Numbers: (1) QBY0002025 QBY0002027 QBY0001994 QBY0001993 QBY0002001 QBY0002006 QBY0002008 QBY0002002 QBY0002003 QBY0002007 QBY0002010 QBY0002004 QBY0002036 QBY0002040 QBY0002042 QBY0002044 QBY0002039 QBY0002035 QBY0002034 QBY0002033 QBY0002026 QBY0002041 QBY0002037 QBY0002051 QBY0002052 QBY0002055 QBY0002054 QBY0002058 QBY0002056 QBY0002301 QBY0002059 QBY0002311 QBY0002352 QBY0002429 QBY0002478 QBY0002529 QBY0002628 QBY0002695 QBY0002696 QBY0002698 QBY0002710 QBY0002711 QBY0002740 QBY0002742 QBY0002741 QBY0002778 QBY0002795 QBY0002820 QBY0002818 QBY0002811 QBY0002834 QBY0002827 QBY0002828 QBY0002829 QBY0002830 QBY0002831 QBY0002836 QBY0002838 QBY0002843 QBY0002844 QBY0002859 QBY0002860 QBY0002926 QBY0002927 QBY0002936 QBY0002909 QBY0002935 QBY0002937 QBY0002938 QBY0003040 QBY0003162 QBY0003185 QBY0003215 QBY0003216 QBY0003135 QBY0003137 QBY0003141 (2) Lot/Serial Number QBY0002279 QBY0002294 QBY0002295 QBY0002293 QBY0002305 QBY0002284 QBY0002280 QBY0002299 QBY0002298 QBY0002296 QBY0002278 QBY0002290 QBY0002287 QBY0002281 QBY0002289 QBY0002277 QBY0002285 QBY0002378 QBY0002377 QBY0002384 QBY0002380 QBY0002386 QBY0002387 QBY0002388 QBY0002394 QBY0002390 QBY0002392 QBY0002391 QBY0002396 QBY0002398 QBY0002395 QBY0002399 QBY0002472 QBY0002482 QBY0002483 QBY0002484 QBY0002485 QBY0002518 QBY0002521 QBY0002522 QBY0002524 QBY0002525 QBY0002528 QBY0002535 QBY0002536 QBY0002537 QBY0002538 QBY0002539 QBY0002540 QBY0002541 QBY0002544 QBY0002550 QBY0002551 QBY0002561 QBY0002562 QBY0002567 QBY0002568 QBY0002577 QBY0002578 QBY0002579 QBY0002580 QBY0002614 QBY0002617 QBY0002620 QBY0002621 QBY0002667 QBY0002666 QBY0002681 QBY0002685 QBY0002686 QBY0002688 QBY0002689 QBY0002691 QBY0002692 QBY0002693 QBY0002705 QBY0002706 QBY0002707 QBY0002708 QBY0002760 QBY0002835 QBY0002761 QBY0002888 QBY0002891 QBY0002892 QBY0002959 QBY0003220 QBY0003221 QBY0003225 QBY0003227 QBY0003228 QBY0003229 QBY0003230 QBY0003231 QBY0003311 QBY0003321; (2) QBY0002306 QBY0002616

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1701-2019

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