Philips Efficia CMS200 Central Monitoring System Recalled for Pediatric Alarm Defect
Philips is recalling 156 Efficia CMS200 central monitoring systems because they may not alarm appropriately for pediatric or neonatal patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a failure to alarm for vulnerable patient populations (pediatric/neonatal), which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 156 units of the Efficia CMS200 Central Monitoring System (Model 863352). The recall was initiated because the monitor may not alarm appropriately for a pediatric or neonatal patient. The device is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices.
The affected devices were distributed worldwide, including in Austria, Bangladesh, Bulgaria, Chile, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Myanmar, Philippines, Poland, Portugal, Saudi Arabia, Thailand, Turkey, United Arab Emirates, United Kingdom, and United Republic of Tanzania. The source text explicitly states that there is no US distribution for these specific units.
Healthcare facilities should identify affected devices by checking the serial numbers listed in the recall documentation. Users should contact Philips for instructions on how to address the alarm functionality issue for pediatric and neonatal patients.
The recalled product
- Product
- Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and…
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 156
Distribution
Distribution scope not specified by the agency.
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