Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.
This recall has been terminated (originally issued December 24, 2004).
- Recall Initiated
- December 1, 2004
- Posted
- December 24, 2004
- Terminated
- February 10, 2006
- Recall Number
- Z-0370-05
- Quantity
- 44 total units (Thoravision I and II)
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
X-Ray system may fall downward and could possibly hit the patient.
Distribution
The firm distributed this product to hospitals and medical centers nationwide.
Lot / Code Info
See the site numbers listed for the Thoravision I. The listed site numbers include both Thoravision I and II products.
Root Cause
Other
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.
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