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Recall Observatory FDA recall evidence

Device product

Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

Z-0902-2013

January 31, 2013

Class II

Product summary

Firm
Salyer Prn Biomedical
Event
Event 64383
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-0902-2013

Official wording

Reason: Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.

Code information: Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.

Distribution pattern: Distributed in the states of MA,CA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.