FDA Device

Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811

Hazard

X-Ray system may fall downward and could possibly hit the patient.

What You Should Do

Remedy

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.

Products

Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
Brand
Philips Medical Systems Sales & Service Region No. America
UPC
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.

Units Affected

44 total units (Thoravision I and II)