GE CARESCAPE PDM monitor SpO2 display freezes during extended use
GE Healthcare's CARESCAPE PDM-Masimo SpO2 physiological monitor displays can freeze after extended use without power down, preventing real-time oxygen saturation monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a physiological monitoring device. The frozen SpO2 display represents a functional failure in vital sign monitoring, justifying High severity; however, no reported illnesses or injuries and no Class I designation prevent a higher score.
Plain-English summary
GE Healthcare is recalling 111,728 units of the CARESCAPE PDM-Masimo SpO2 physiological data monitor. The device can experience a malfunction in which SpO2 (oxygen saturation) display values become frozen after extended use without power down. When frozen, the values cannot be updated to reflect current patient status.
The frozen display prevents the monitor from displaying real-time SpO2 measurements. This affects the ability to continuously observe patient oxygen saturation levels during clinical use.
The affected devices were distributed worldwide, including throughout the United States and internationally. Multiple model numbers and associated software components are included in this FDA Class II recall.
The recalled product
- Product
- CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 111,728
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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