FDASeptember 7, 2018device

APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.

What to do

FDA enforcement status: Terminated

Brands named

abbott laboratoriesabbott

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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