Abbott APS Accelerator Modules Recalled for Missing Pacemaker Safety Label
Abbott is recalling 159 APS Accelerator modular systems because the safety pacemaker label is missing. The Operations Manual has been updated to specify a 200 mm minimum safety distance for pacemaker wearers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a missing label and updated safety distance without reporting any actual injuries, illnesses, or malfunctions. This aligns with the rubric for moderate severity involving labeling errors or theoretical risks where harm has not been reported.
Plain-English summary
Abbott Laboratories, Inc. is recalling 159 APS Accelerator modular systems (208-230 V, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product) because the safety pacemaker label is missing from the modules. The firm identified customer sites where this specific labeling deficiency exists.
The hazard involves the risk of malfunction for individuals with pacemakers who may work on these modules. Information in the Operations Manual has been updated to clarify that the minimum safety distance from transport mechanisms has increased to 200 mm (7.87 inches). Any person with a pacemaker must not get closer than this distance from the modules' axes.
The affected devices were distributed in the United States and internationally. Consumers and healthcare facilities should check their inventory for the missing label and refer to the updated Operations Manual for safety instructions regarding pacemaker wearers.
The recalled product
- Product
- APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
- Manufacturer
- Abbott Laboratories, Inc
- Affected units
- 159
Distribution
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