PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 2, 2019 Initiated: September 7, 2018 #Z-2755-2019

Product Description

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.

Details

Recalling Firm
Abbott Laboratories, Inc
Units Affected
159 devices
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
Location
Irving, TX

Frequently Asked Questions

What product was recalled? ▼
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,. Recalled by Abbott Laboratories, Inc. Units affected: 159 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2019. Severity: Moderate. Recall number: Z-2755-2019.

Related Recalls

FDA Devices Moderate

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Fujirebio Diagnostics, Inc. · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →