Reported Oct 2, 2019 · Terminated
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Abbott Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories, Inc · 1921 Hurd Dr · Irving, TX · 75038-4313
Is this the product you have?
- APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
- Lot codes and dates
- All Lot Numbers
100 of 100 codes
ABT018ABT070ABT107ABT135ABT019ABT074ABT108ABT136ABT023ABT075ABT109ABT137ABT024ABT077ABT110ABT138ABT026ABT078ABT111ABT139ABT027ABT081ABT112ABT140ABT028ABT082ABT113ABT142ABT034ABT083ABT114ABT143ABT036ABT084ABT116ABT144ABT037ABT086ABT117ABT145ABT041ABT088ABT118ABT146ABT042ABT089ABT119ABT147ABT047ABT091ABT120ABT149ABT049ABT092ABT121ABT150ABT050ABT093ABT122ABT151
- All Lot Numbers
- Amount recalled
- 159 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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