FlexLab — Class II medical device recall Z-0361-2019
Terminated recall by Inpeco S.A., reported 2018-11-07. The firm has identified customer sites where there are modules on which the safety pacemaker label is missing.
| Recall number | Z-0361-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, N/A, Switzerland |
| Recall initiated | 2018-08-24 |
| Classified | 2018-10-31 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-03-19 |
| Countries outside the US | AT, BE, DE, ES, FR, IT, NL |
| Quantity | 679 |
| Reason classes | labeling, device malfunction |
Product
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
Reason for recall
The firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has been increased to 200 mm (7.87") from the transport mechanisms. Any person with a pacemaker must not get closer than this distance from the 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-0361-2019. 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.