Spacelabs Ventilator Interface Recalled for Minute Volume Display Error
Spacelabs Healthcare is voluntarily recalling Ventilator Flexport Interfaces because the bedside monitor may display minute volume values up to ten times the actual value.
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 with a significant display error that could lead to incorrect clinical decisions, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Spacelabs Healthcare Inc is voluntarily recalling the Hamilton Galileo Ventilator Flexport Interface, Model 90436A-07. The recall is due to a defect where the monitored Minute Volumes (Vmin) have been reported to reach ten times the actual value on the bedside monitor.
The recall affects 46 units distributed within the United States and 108 units distributed outside the US. US distribution was nationwide, including the states of Arizona, Indiana, Louisiana, Georgia, South Carolina, Florida, and New York. The product was also distributed to 18 customers outside the US.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should stop using the affected interfaces and contact Spacelabs Healthcare for instructions on corrective action.
The recalled product
- Product
- Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
- 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 Distributed in the US: 436A000660
- 436A000663
- 436A000664
- 436A000666
- 436A000667
- 436A000669
- 436A004306
- 436A004307
- 436A004308
- 436A004309
- 436A004310
- 436A006122
- 436A006123
- 436A006441
- 436A006442
- 436A006443
- 436A006444
- 436A006452
- 436A006573
- 436A006589
Distribution
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