Recall record at a glance
| Official record | Z-1577-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Spacelabs Healthcare Inc. |
| Report date | May 13, 2015 |
| Recall initiation date | Apr 21, 2015 |
| Quantity | 1973 units total (1345 modules in the US and 604modules international and 3 PCBAs in US and 21 PCBAs international) |
| Location | Snoqualmie, WA, United States |
Official product description
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
Why the product was recalled
Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.
Distribution information
Worldwide Distribution:US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, ID, IL, LA, ME, MI, MN, MO, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WY, and Puerto Rico and countries of: Argentina, Australia, Bangladesh, Canada, Chile, France, Great Britain, India, Kuwait, Panama, Poland, Qatar, Saudi Arabia, and Turkey. .
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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