# FDA recall Z-2755-2019

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2018-09-07.

## Product

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

## Reason for recall

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.

## 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, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, UAE, UK,  Venezuela

## Key facts

- **Recall number:** Z-2755-2019
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-07
- **Report date:** 2019-10-02
- **Termination date:** 2021-02-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2755-2019

## Citation

> AI Analytics. FDA recall Z-2755-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2755-2019. Source: US FDA. Licensed CC0.

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