Respironics RP-UI Assy — Class II medical device recall Z-1153-2020
Ongoing recall by Respironics California, LLC, reported 2020-02-19, distributed nationwide. Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change
| Recall number | Z-1153-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respironics California, LLC, Carlsbad, CA, United States |
| Recall initiated | 2019-09-11 |
| Classified | 2020-02-12 |
| Reported by FDA | 2020-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CL, CN, CO, DE, EC, ES, FI, FR, GB, GR, GT, HK, HR, ID, IL, IN, IS, IT, MX, MY, NL, OM, PE, PH, PL, PT, SA, SE, SG, TR, TW, VN, ZA |
| Quantity | 56 |
| UPC / GTIN / UDI-DI | 00453561528931 |
| Serial numbers | 100256192, 100256195, 100256196, 100256197, 100256198, 100256199, 100256220, 100256222, 100256223, 100256831, 100256834, 100256837, 100257708, 100257713, 100257716, 100258193, 100258196, 100258197, 100258880, 100258881, 100258883, 100258884, 100258885, 100258886, 100258887 and 32 more |
| Model numbers | 453561528931, 453561528941, 453561536451, 453561536461 |
Product
Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
Reason for recall
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
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-1153-2020. 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.