Spacelabs Ultraview SL Command Modules Recalled for Random Resets
Spacelabs is recalling Ultraview SL Command Modules with specific Masimo SpO2 components due to a defect causing random resets.
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: The recall is classified as FDA Class II, and the hazard involves a medical device that monitors clinical parameters. While no specific injuries are reported in the text, the risk of harm from device malfunction in a clinical setting aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Spacelabs Healthcare Inc is recalling Ultraview SL Command Modules, Model 91496, that are configured with the Masimo SpO2 option and the Masimo SpO2 PCBA (PN: 010-1636-02). The recall involves 1,973 units total, including 1,345 modules in the US and 604 modules internationally, as well as 3 PCBAs in the US and 21 PCBAs internationally.
The recall is due to a failure mode where the modules may experience random resets. This issue occurs specifically when the module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R), and the Masimo SpO2 PCBA. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from adult or neonate/infant populations in clinical environments other than home use.
The affected products were distributed worldwide, including in the US (nationwide) and in countries such as Argentina, Australia, Bangladesh, Canada, Chile, France, Great Britain, India, Kuwait, Panama, Poland, Qatar, Saudi Arabia, and Turkey. Spacelabs expanded the recall on June 4, 2015, to include additional serial numbers.
The recalled product
- Product
- Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or…
- Manufacturer
- Spacelabs Healthcare Inc
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)
- FIRM EXPANDED RECALL ON JUNE 4
- 2015 TO INCLUDE ADDITIONAL 29 SERIAL NUMBERS IN THE US: 1496-005416
- 1496-005717
- 1496-005727
- 1496-005734
- 1496-005735
- 1496-005737
- 1496-005739
- 1496-005744
- 1496-005745
- 1496-005746
- 1496-005760
- 1496-008609
- 1496-008614
- 1496-008918
- 1496-009096
- 1496-009666
- 1496-010906
- 1496-014637
- 1496-022087
Distribution
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