Spacelabs Healthcare Ultraview SL Multigas Module recall: Software Issue
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations…
Why was Spacelabs Healthcare Ultraview SL Multigas Module recalled?
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209
- Product
- Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations…
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 8 units total (3 units in US)
- Distribution
- Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
- Recall date
- July 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)