Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.
FDA device recall Z-0786-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The CT couch may move downward to its lower limit without command.
- Action taken
- The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 385 units
- Distribution
- The systems were installed at medical facilities located nationwide and worldwide.
- Date initiated
- 2004-03-08
- Date posted
- 2004-07-20
- Date terminated
- 2008-10-29
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |