HeartStart XL Defibrillator/Monitor, Model: M4735A
FDA device recall Z-0062-2008 · posted 2007-10-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.
- Action taken
- Philips Medical notified accounts (Distributors/Healthcare Customers) by letter dated 9/4/07. Users are requested if possible to remove the unit from service. Firm will have Field representative conduct correction.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 147 boards
- Distribution
- Puerto Rico, Canada, Argentina, Australia, Brazil, China, Domincan Republic, Czech Republic, Hong Kong, India, Japan, Korea, Macau, Singapore, Spain, South Africa, Slovenia, Sweden, Switzerland, Irela
- Date initiated
- 2007-09-04
- Date posted
- 2007-10-25
- Date terminated
- 2016-08-09
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A (K021453) | Philips Medical Systems | 2002-07-03 |