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[Recalled] Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures. — Concerns that the addition of the UPS Battery Backup to

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductCentury Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Brand / manufacturerSalyer Prn Biomedical
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0902-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date31 January 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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