Device product
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Z-2206-2021
Product summary
- Event
- Event 88199
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2206-2021
Official wording
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Code information: Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 07613327282566
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Derived failure modes
-
Unknown
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals