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U.S. Department of Health and Human Services

Class 2 Device Recall Thoravision I

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 Class 2 Device Recall Thoravision Isee related information
Date Initiated by FirmDecember 01, 2004
Date PostedDecember 24, 2004
Recall Status1 Terminated 3 on February 10, 2006
Recall NumberZ-0369-05
Recall Event ID 30569
510(K)NumberK931071 K981657 
Product Classification System, X-Ray, Stationary - Product Code KPR
ProductThoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
Code Information 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.
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Hwy
Bothell WA 98021
For Additional Information ContactSarah Baxter
425-487-7665
Manufacturer Reason
for Recall		X-Ray system may fall downward and could possibly hit the patient.
FDA Determined
Cause 2		Other
ActionA 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.
Quantity in Commerce44 total units (Thoravision I and II)
DistributionThe firm distributed this product to hospitals and medical centers nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR
510(K)s with Product Code = KPR
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