Spacelabs Medical Ultraview SL Command Module recall: Software Issue
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care…
Why was Spacelabs Medical Ultraview SL Command Module recalled?
A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
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?
All devices of Model: 91496.
- Product
- Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care…
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 64 devices
- Distribution
- US Distribution to GA.
- Recall date
- June 11, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)