Z-1704-2019 Class II Terminated
FDA device recall Z-1704-2019 was initiated by Angiodynamics Inc. (Navilyst Medical Inc.) on April 17, 2019 and is designated Class II. 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 The recall status is terminated (terminated June 9, 2020). Affected quantity: 1846.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- April 17, 2019
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1846
Product Description
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
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
Distribution Pattern
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
Code Information
Serial Numbers: (1) 16480626 17150699 17160704 17170705 17170706 17310766 17370790 17380795 17390797 17420814 17420817 17430823 17460844 17460847 17470850 5377356 (2) 17200721 17210722 17220730 17220731 17220732 17250743 17270749 17300765 17320771 17380794 17400805 17420816 17440830 17470849 5346596 5355835 5385267 5392055 5392056 5416590 5426407 5446902