Spacelabs Ultraview SL Integrated Module Housing Recalled for Potential Failure
Spacelabs Healthcare is recalling Ultraview SL Integrated Module Housings because they may fail, causing patient module parameters to drop off the monitor display or preventing modules from signing on.
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 a failure could lead to the loss of patient monitoring data or alarm functionality. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as the source does not state that any injuries or illnesses have occurred.
Plain-English summary
Spacelabs Healthcare, LLC is recalling the Ultraview SL 91493 Integrated Module Housing. The recall involves 527 units total, with 350 units distributed in the US and 177 units distributed internationally.
The recall is due to a potential failure of the Integrated Module Housing. This failure can cause patient module parameters to drop off the monitor display or cause the patient module to fail to sign on when inserted into the housing. The PCIS patient monitors are intended to sound various alarm tones generated by specific patient parameter modules and display alarm conditions.
The affected units were distributed worldwide. Specific serial numbers for domestic and international units are listed in the official recall record. No specific instructions for consumers are provided in the source text, but the recall is managed by Spacelabs Healthcare, LLC.
The recalled product
- Product
- Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm…
- Manufacturer
- Spacelabs Healthcare, Llc
- Category
- Medical Device — Patient Monitor
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)
- Domestic - 1493-000275
- 1493-000276
- 1493-000277
- 1493-002469
- 1493-002616
- 1493-003358
- 1493-003359
- 1493-003667
- 1493-003668
- 1493-003669
- 1493-003670
- 1493-003671
- 1493-003672
- 1493-003673
- 1493-003674
- 1493-003675
- 1493-003676
- 1493-003677
- 1493-003678
- 1493-003679
Distribution
Distribution scope not specified by the agency.
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