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Recall Observatory FDA recall evidence

Device product

ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems

Z-1879-2014

November 28, 2012

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 64247
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-1879-2014

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: 98-0049, 98-0051; Serial Numbers: 2000729, 2000761

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

    reason.no_named_rule · v1.0.0

    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.