LIFEPAK CR Plus defibrillator
FDA device recall Z-0940-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Medtronic Physio Control Corp
- Reason for recall
- Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
- Action taken
- On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 7095 devices
- Distribution
- The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay.
- Date initiated
- 2003-05-23
- Date posted
- 2003-06-12
- Date terminated
- 2004-02-24
- Location
- Redmond, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR (K011144) | Medtronic Physio-Control Corp. | 2001-12-03 |