Spacelabs Healthcare, Inc.: Detector And Alarm, Arrhythmia
Recall Summary Spacelabs Healthcare is recalling its Ultraview SL Command Module (model 91496), a core component of patient monitoring systems used in hospitals, due to a manufacturing defect in an electrical leakage tester. The affected devices were distributed nationwide across the US and in Argentina. This is a Class II recall, meaning the device could cause serious adverse health effects or death.
- Recalling firm
- Spacelabs Healthcare, Inc.
- Product
- Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
- Reason
- Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/033f297d-a5bf-4b06-ab2c-663804c690f3