RX Imola — Class II medical device recall Z-2084-2019
Terminated recall by Randox Laboratories, Limited, reported 2019-07-31, distributed in CA, CT, MA, MD, MO, NC, NJ, NY…. There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to me
| Recall number | Z-2084-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Limited, Crumlin, N/A, United Kingdom |
| Recall initiated | 2019-06-24 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-05-21 |
| Distributed | CA, CT, MA, MD, MO, NC, NJ, NY, OH, PA, PR, UT, WV |
| Quantity | 27 |
| Reason classes | device malfunction |
| Model numbers | RX4900 |
Product
RX Imola, Model Nos. RX4900
Reason for recall
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
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-2084-2019. 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.