biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXX
FDA device recall Z-1148-2007 · posted 2007-08-04 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.
- Action taken
- On June 13, 2007 the recalling firm sent a letter dated June 11, 2007, titled URGENT - MEDICAL DEVICE CORRECTIVE ACTION. The letter advises of the situation, recommends to the consignee to set defibrillator to FIXED Sequence Protocol and to contact the firm for a FLEXIBLE Sequence Energy Protocol. The letter provides an instruction sheet and a response sheet to be faxed back to the company.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKT
- Quantity affected
- 59,996 devices
- Distribution
- Worldwide
- Date initiated
- 2007-06-13
- Date posted
- 2007-08-04
- Date terminated
- 2011-03-20
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 500 (K955854) | Physio-Control Corp. | 1996-11-04 |