Device product
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
Z-1881-2014
Product summary
- Event
- Event 64247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21
- Official record key
device-enforcement:Z-1881-2014
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 Numbers: 98-0002, 98-0004, 98-0007, 98-0030, 98-0036; Serial Numbers: 200245, 20032601, 20032602 20032603, 20032604, 20032504, 20032508, 20032502, 20032503, 20032506, 20032702, 20032701, 20032507, 20032501, 20032505, 200027203, 200027201, 200027202, 200064104.
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.