FDA Device recall Z-2139-2021
CARESCAPE PDM-Masimo SpO2. Physiological data monitor
- FDA Device
- Class II
- ongoing
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of CARESCAPE PDM-Masimo SpO2. Physiological data monitor by Ge Healthcare, citing masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2139-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-21 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Reason
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Identifiers
| code_info | CARESCAPE PDM: product codes SA3, SPX; model numbers 2042084-001, 2094504-001, 2016793-002, 2016793-003; Software kit…CARESCAPE PDM: product codes SA3, SPX; model numbers 2042084-001, 2094504-001, 2016793-002, 2016793-003; Software kits, field replaceable units, and upgrade kits: part numbers 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, 2031069-010, 2045825-001, 2045825-002, 2045825-004, 2045825-005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2139-2021%22
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