Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
FDA device recall Z-1128-2007 · posted 2007-08-07 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- The ECG signal may become unusable to assess patient condition and need for therapy.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 312 units
- 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, Sloven
- Date initiated
- 2007-06-11
- Date posted
- 2007-08-07
- Date terminated
- 2016-08-08
- Location
- Andover, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A (K021453) | Philips Medical Systems | 2002-07-03 |