Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
This recall has been terminated (originally issued August 7, 2007).
- 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
- Official Source
- View on FDA website ↗
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.