Device product
CoolSeal Generator, REF: CSL-200-50
Z-0736-2022
Product summary
- Event
- Event 89570
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-0736-2022
Official wording
Reason: A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.
Code information: Serial Numbers: 00161-170, UDI: 00850346007023
Distribution pattern: US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Derived failure modes
-
Manufacturing or process control
manufacturing/assembly defect