ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with An...
FDA Recall #Z-1897-2014 — Class II — November 28, 2012
Product Description
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
Reason for Recall
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.
Recalling Firm
The Anspach Effort, Inc. — Palm Beach Gardens, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
45
Distribution
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. .
Code Information
Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated