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.
What this means for you
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 vital
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 156
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Philips Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12