CARESCAPE PDM-Masimo SpO2 — Class II medical device recall Z-2139-2021
Ongoing recall by GE Healthcare, LLC, reported 2021-08-04, distributed nationwide. Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
| Recall number | Z-2139-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-05-21 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BM, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, HU, ID, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LT, MA, MX, MY, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, TH, TN, TR, TT, TW, UY, VE, VN, ZA |
| Quantity | 111,728 units |
| Model numbers | 2016793-002, 2016793-003, 2031069-010, 2034826-001, 2034826-002, 2034826-003, 2034826-004, 2034826-005, 2034826-006, 2034826-007, 2034826-008, 2034826-009, 2034826-010, 2034826-011, 2034826-012, 2034826-013, 2042084-001, 2045825-001, 2045825-002, 2045825-004, 2045825-005, 2094504-001 |
Product
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Reason for recall
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
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-2139-2021. 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.