AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 178 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient harm due to procedure delays, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling 178 units of the Solero Microwave Tissue Ablation (MTA) System. The affected products include the Solero Generator Refurbished PG (Catalog Number 12740000D) and the Solero Generator Refurbished US PG (Catalog Number 12740000USD). These devices were distributed worldwide, including in the United States and numerous international markets.
The recall is being conducted to update the Warning Statements in the Operator's Manual/Directions for Use and to provide software updates. These changes are intended to reduce the risk of potential patient harm caused by a delay in performing a procedure. The source text does not specify the number of reported injuries or illnesses associated with this issue.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the official recall notice. Users should contact AngioDynamics Inc. for instructions on how to obtain the updated software and revised documentation to ensure safe operation of the device.
The recalled product
- Product
- 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
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 178
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- (2) QBY0002306 QBY0002616
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Angiodynamics Inc. (Navilyst Medical Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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