Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.
FDA device recall Z-0370-05 · posted 2004-12-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- X-Ray system may fall downward and could possibly hit the patient.
- Action taken
- A notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 44 total units (Thoravision I and II)
- Distribution
- The firm distributed this product to hospitals and medical centers nationwide.
- Date initiated
- 2004-12-01
- Date posted
- 2004-12-24
- Date terminated
- 2006-02-10
- Location
- Bothell, WA
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