Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
- Company
- Philips Medical Systems
- Recall Initiated
- June 11, 2007
- Posted
- August 7, 2007
- Terminated
- August 8, 2016
- Recall Number
- Z-1128-2007
- Quantity
- 312 units
- Firm Location
- Andover, MA
Reason for Recall
The ECG signal may become unusable to assess patient condition and need for therapy.
Distribution
Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.
Lot / Code Info
Serial Numbers: US00453441 through US00453910
Root Cause
Nonconforming Material/Component
Action Taken
Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.
More recalls by Philips Medical Systems
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning S...
Feb 2, 2016
Philips M8000-64100 Table Mount
Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas...
Jan 13, 2009
Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed...
Dec 31, 2008