Recall Z-2755-2019— Abbott Laboratories, Inc
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2018-09-07, terminated 2021-02-02. It names one FDA 510(k) clearance: K093318. Product: APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,. Reason: 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..
- Recalling firm
- Abbott Laboratories, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-07
- Terminated
- 2021-02-02
- Firm location
- Irving, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.