Spacelabs Ultraview SL Command Modules Recalled for Monitoring Suspension
Spacelabs is recalling Ultraview SL Command Modules upgraded with the Masimo SpO2 Option because monitoring suspends for approximately 10 seconds during 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 involves a medical device where monitoring is suspended for a short duration, creating a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Spacelabs Healthcare Inc is recalling Ultraview SL Command Modules, Model 91496-M, that were upgraded with the Masimo SpO2 Option. The recall involves 1,999 units, with 1,932 units distributed in the United States and 67 units distributed internationally, including in France.
The recall was initiated after customers reported that during a module reset, which lasts approximately 10 seconds, the monitoring of all clinical parameters is suspended. Upon completion of the reset sequence, alarms are reset to their default values. The affected modules are intended for use with the Patient Care Management System to monitor clinical parameters in adult or neonate/infant populations in clinical environments other than home use.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. The recall covers units distributed in specific US states and France. No specific consumer action is detailed in the source text beyond the identification of affected serial numbers.
The recalled product
- Product
- Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: 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…
- 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)
- SERIAL NUMBERS IN THE US: 1496-000473
- 1496-000590
- 1496-001126
- 1496-001189
- 1496-001214
- 1496-001299
- 1496-001300
- 1496-001301
- 1496-001302
- 1496-001303
- 1496-001304
- 1496-001305
- 1496-001306
- 1496-001307
- 1496-001309
- 1496-001328
- 1496-001329
- 1496-001330
- 1496-001332
- 1496-001333
Distribution
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