TactiSys Quartz Equipment — Class II medical device recall Z-1493-2019
Terminated recall by Abbott Laboratories Inc. (St Jude Medical), reported 2019-06-05. In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills t
| Recall number | Z-1493-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical), Saint Paul, MN, United States |
| Recall initiated | 2019-04-05 |
| Classified | 2019-05-25 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2021-04-27 |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CN, CZ, DE, DK, EG, ES, FR, GB, GR, IE, IL, IR, IT, JO, JP, LB, MA, MY, NL, NO, NZ, OM, PL, PT, RO, RS, RU, SE, SG, SI, SK, SV, TH, TR, TW, ZA |
| Quantity | 317 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07640157990194 |
| Serial numbers | 33011, 33012, 33013, 33014, 33015, 33016, 33018, 33019, 33020, 33021, 33022, 33023, 33024, 33025, 33027, 33028, 33029, 33031, 33032, 33033, 33034, 33035, 33037, 33038, 33040 and 300 more |
| Model numbers | 400, 600043767, PN-004 |
Product
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Reason for recall
In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.
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-1493-2019. 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.