The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentrat
FDA device recall Z-2573-2011 · posted 2011-06-20 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.
- Action taken
- Spacelabs Medical sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 12, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. Customers were recommended to set all their Capnography Module Configuration Manager alarm settings to "ON". The letter also recommended that customers brief their staff about the possibility of losing changes to the default settings and to restore them after a power interruption. A field service engineer will be contacting customers to set up a date and time when affected modules can be upgraded at no cost to the customer. For questions about this corrective action program, call Spacelabs Medical at 1-800-522-7025, Select 2 for Technical Support. For outside the US, customers can call 1-425-657-7200, x5089.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 5883 units
- Distribution
- Worldwide Distribution--USA (nationwide) and countries of ALGERIA, ARGENTINA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA,COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN
- Date initiated
- 2011-05-12
- Date posted
- 2011-06-20
- Date terminated
- 2011-12-02
- Location
- Issaquah, WA
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Related 510(k) clearances
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| POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR (K031124) | Datex-Ohmeda, Inc. | 2003-12-04 |