Abbott recalls APS Accelerator modular systems with missing safety pacemaker labels. These systems require 200mm distance from pacemaker users to prevent malfunction risks.
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.
Abbott is recalling certain APS Accelerator modular systems because they may lack a critical safety pacemaker label. This means people with pacemakers could face malfunction risks if they get too close to the equipment.
The recalled systems may not have the safety pacemaker label required by the manufacturer. If a person with a pacemaker gets closer than 200mm to the equipment, there's a risk of malfunction that could affect their health.
People with pacemakers who use or work near these modular systems are at risk. Those without pacemakers are not affected by this recall.
Check for the safety pacemaker label on the equipment. The recalled units have specific lot numbers listed in the recall notice, including ABT018, ABT070, and other combinations.
Look for the safety pacemaker label on the equipment. If missing, the unit is part of the recall.
If you have a pacemaker, keep at least 200mm (7.87 inches) away from the equipment axes to prevent malfunction risks.
No, but if you have a pacemaker, you must maintain a 200mm distance from the equipment to avoid risks.
The affected lot numbers include ABT018, ABT070, ABT107, ABT135, and other combinations listed in the recall notice.
The recall does not mention a fix; the remedy is not specified in the record.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2755-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2755-2019 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
