Recall Z-0104-2015— Philips Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-10-03, terminated 2017-01-31. It names 2 FDA 510(k) clearances: K131913, K122439. Product: Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.. Reason: Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped.
- Recalling firm
- Philips Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-03
- Terminated
- 2017-01-31
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K131913 — INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
- K122439 — INTELLIVUE PATIENT MONITOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
Reason for recall
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
Data sourced from openFDA. This site is unofficial and independent of the FDA.