Synchron CX4, CX5 and CX9 Pro Systems.
FDA device recall Z-0067-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
- Action taken
- Product Corrective Action letter was sent the week of 9/29/2003 by US MAIL with a fax back card.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 351
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-09-29
- Date posted
- 2003-10-24
- Date terminated
- 2004-04-05
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (K011465) | Beckman Coulter, Inc. | 2001-06-08 |
| SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 (K951189) | Beckman Instruments, Inc. | 1995-06-13 |