Recalls / —
—#53227
Product
Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
- FDA product code
- MKJ — Automated External Defibrillators (Non-Wearable)
- Device class
- Class 3
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K021453
- Affected lot / code info
- Serial Numbers: US00453441 through US00453910
Why it was recalled
The ECG signal may become unusable to assess patient condition and need for therapy.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Philips Medical Systems
- Address
- 3000 Minuteman Road, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2007-06-11
- Posted by FDA
- 2007-08-07
- Terminated
- 2016-08-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #53227. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.