Reported Aug 4, 2021 · Ongoing
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 product codes SA3, SPX 2 model numbers 2042084-001, 2094504-001, 2016793-002, 2016793-003 3 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 - Amount recalled
- 111,728 units
Where it was sold
- Nationwide
Why it was recalled
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
This product could cause temporary or reversible health problems — stop using it.
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