Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a
FDA device recall Z-2077-2014 · posted 2014-07-17 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare Inc
- Reason for recall
- With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
- Action taken
- Spacelabs sent an Urgent Medical Device Correction letter dated June 20, 20/14 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers are informed that Spacelabs Field Service personnel will be contacting their facility to schedule a convenient time to confirm, at no cost, a software update is needed to resolve this issue. Customers with questions are instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CBR
- Quantity affected
- 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.
- Date initiated
- 2014-06-18
- Date posted
- 2014-07-17
- Date terminated
- 2014-12-08
- Location
- Snoqualmie, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPEACELABS MULTIGAS MODULE (K112173) | Spacelabs Healthcare | 2011-10-05 |