Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
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-0369-05
- 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
The firm uses site numbers instead of serial numbers. The listed site numbers include both Thoravision I and II products. 83956, 13253, 13917, 86223, 25709, 38975, 17579, 13610, 17506, 50321, 100322, 13919, 45032, 44803, 26294, 82617, 76802, 100633, 41354, 26058, 100693, 76806, X0212, 62971, 76374, 59408, 6960, 38715, 10405, 40932, 50319, 50320, 59670, 62972, 86451, X1068, 47101, 47167, 17620, 26214, 76020, 76021, 41437, 38989.
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.