medical Class II Updated 2021-08-04

GE Healthcare, LLC recalls CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Recalled Product

CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

Hazard / Issue

Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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