APS Accelerator modular systems — Class II medical device recall Z-2755-2019
Terminated recall by Abbott Laboratories, Inc, reported 2019-10-02, distributed in AZ, CA, CT, FL, IL, IN, KS, LA…. The firm identified customer sites where modules which the safety pacemaker label is missing. Information rega
| Recall number | Z-2755-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2018-09-07 |
| Classified | 2019-09-26 |
| Reported by FDA | 2019-10-02 |
| Terminated | 2021-02-02 |
| Distributed | AZ, CA, CT, FL, IL, IN, KS, LA, MA, MN, NC, ND, NJ, NV, NY, PA, SC, TN, TX, VA, WA |
| Countries outside the US | AE, AR, AU, BE, CA, CN, DK, ES, FR, GB, GR, HK, IE, IT, NO, NZ, OM, PH, PK, PT, RU, SA, SG, TR, TW, VE |
| Quantity | 159 devices |
| Reason classes | labeling, device malfunction |
| Lot numbers | ABT018, ABT019, ABT023, ABT024, ABT026, ABT027, ABT028, ABT034, ABT036, ABT037, ABT041, ABT042, ABT047, ABT049, ABT050, ABT051, ABT054, ABT058, ABT059, ABT062, ABT063, ABT065, ABT066, ABT067, ABT068, ABT069, ABT070, ABT074, ABT075, ABT077, ABT078, ABT081, ABT082, ABT083, ABT084, ABT086, ABT088, ABT089, ABT091, ABT092 and 60 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2755-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.