Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the
FDA device recall Z-2401-2012 · posted 2012-09-17 · Terminated
Recall details
- Recalling firm
- ZOLL Medical Corporation
- Reason for recall
- Shipped with incorrect software
- Action taken
- Zoll Medical telephoned affected customers on August 16, 2012. Customers were informed of the affected product, problem and actions to be taken. Customers were instructed to remove and return the affected product for replacement. For question contact ZOLL's Technical Support.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 11 units
- Distribution
- Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
- Date initiated
- 2012-08-16
- Date posted
- 2012-09-17
- Date terminated
- 2012-09-19
- Location
- Chelmsford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL X SERIES (K112432) | Zoll Medical Corporation, World Wide Headquarters | 2012-03-21 |