PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 13, 2015 Initiated: April 21, 2015 #Z-1577-2015

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.

Reason for Recall

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.

Details

Recalling Firm
Spacelabs Healthcare Inc
Units Affected
1973 units total (1345 modules in the US and 604modules international and 3 PCBAs in US and 21 PCBAs international)
Distribution
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. .
Location
Snoqualmie, WA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Spacelabs Healthcare Inc. Units affected: 1973 units total (1345 modules in the US and 604modules international and 3 PCBAs in US and 21 PCBAs international).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2015. Severity: Moderate. Recall number: Z-1577-2015.

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