Use caution Medical device recall · FDA · Published September 7, 2018

Abbott APS Accelerator Systems: Pacemaker Safety Risk

Abbott recalls APS Accelerator modular systems with missing safety pacemaker labels. These systems require 200mm distance from pacemaker users to prevent malfunction risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2755-2019Medical device Abbott ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmAbbott Laboratories, Inc1921 Hurd Dr · Irving, TX 75038-4313

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/69898-abbott-aps-accelerator-systems-pacemaker-safety-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69898-abbott-aps-accelerator-systems-pacemaker-safety-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2755-2019

Cite this page

“Abbott APS Accelerator Systems: Pacemaker Safety Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69898-abbott-aps-accelerator-systems-pacemaker-safety-risk. Based on FDA recall #Z-2755-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2755-2019%22&limit=1).

The FDA announced on Sept. 7, 2018, that Abbott Laboratories is recalling APS Accelerator modular systems because safety pacemaker labels are missing from some units. The agency said the omission increases the risk of malfunction for individuals with pacemakers working near the modules.

How to tell if you have it

Brand: Abbott
Product: APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product
Lot numbers: ABT018, ABT070, ABT107, ABT135, ABT019, ABT074, ABT108, ABT136, ABT023, ABT075, ABT109, ABT137, ABT024, ABT077, ABT110, ABT138, ABT026, ABT078, ABT111, ABT139, ABT027, ABT081, ABT112, ABT140, ABT028, ABT082, ABT113, ABT142, ABT034, ABT083, ABT114, ABT143, ABT036, ABT084, ABT116, ABT144, ABT037, ABT086, ABT117, ABT145, ABT041, ABT088, ABT118, ABT146, ABT042, ABT089, ABT119, ABT147, ABT047, ABT091, ABT120, ABT149, ABT049, ABT092, ABT121, ABT150, ABT050, ABT093, ABT122, ABT151, ABT051, ABT094, ABT123, ABT152, ABT054, ABT096, ABT124, ABT153, ABT058, ABT097, ABT125, ABT154, ABT059, ABT098, ABT126, ABT156, ABT062, ABT099, ABT127, ABT157, ABT063, ABT100, ABT128, ABT158, ABT065, ABT101, ABT129, ABT159, ABT066, ABT102, ABT130, ABT067, ABT104, ABT131, ABT068, ABT105, ABT132, ABT069, ABT106, ABT133
Quantity: 159 devices

The hazard

According to the FDA, the hazard is that modules lack the required safety pacemaker label. The agency stated this creates a risk of malfunction for anyone with a pacemaker who may work on these modules and requires maintaining a minimum safety distance of 200 mm (7.87 inches) from transport mechanisms.

Context

GovInfoNow's records show Abbott Laboratories has issued 11 other recalls since Sept. 29, 2017. Other recent recalls include the Abbott Alinity s System Software Version 2.8.0 Recall on Feb. 3, 2022, and the Abbott ARCHITECT C System Mixer Recall on May 1, 2019. Recent similar product recalls include Boston Scientific CRT-P Pacemakers requiring a software update for safety on March 19, 2026, and the Abbott Medical Merlin PCS 365 recall on May 12, 2026.

How to tell if you have this one

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.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Safety Label
Look for the safety pacemaker label on the equipment. If missing, the unit is part of the recall.
Maintain Safe Distance
If you have a pacemaker, keep at least 200mm (7.87 inches) away from the equipment axes to prevent malfunction risks.

Where it went and when

Where it was distributed

Distributed in 21 states, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Connecticut, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Nevada, New Jersey, New York, North Carolina, North Dakota, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Sep 7, 2018Firm started the recall
Sep 26, 2019FDA classified it Class II
Oct 2, 2019Published in FDA’s Enforcement Report
Feb 2, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69898-abbott-aps-accelerator-systems-pacemaker-safety-risk">Abbott APS Accelerator Systems: Pacemaker Safety Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2755-2019 (September 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2755-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.