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

Recall date

September 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2755-2019

FDA classification

Class II

Brand / firm

Abbott Laboratories, Inc

Sold / distributed

US: TX, VA, AZ, NV, MA, LA, MN, PA, SC, NJ, NY, CA, IL, IN, WA, FL, TN, PA, KS, ND, NC, CT OUS: Argentina, Australia, Belgium, Canada, China, Denmark, France, Greece, Hong Kong, Ireland, Italy, New Zealand, Norway, Oman, Pakistan, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Spain, Taiwa…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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