Device product
ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
Z-1884-2014
Product summary
- Event
- Event 64247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1884-2014
Official wording
Reason: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Code information: Part Number: 98-0008; Serial Numbers: 20033001, 20033002.
Distribution pattern: Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
Derived failure modes
-
Unknown
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.