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
Reported: June 12, 2019 Initiated: April 17, 2019 #Z-1701-2019
Product 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
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
Details
- Recalling Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Units Affected
- 178 units
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of AE AT AU BE CA CH CL CO CZ DE DK DZ EG ES FR GB GE GR HK IE IL IN IQ IT LB LT MC MT MX NL NZ PL PT SG TH TR TW VN ZA
- Location
- Glens Falls, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: 178 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1701-2019.
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