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Class 2 Device Recall Thoravision I |
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Date Initiated by Firm |
December 01, 2004 |
Date Posted |
December 24, 2004 |
Recall Status1 |
Terminated 3 on February 10, 2006 |
Recall Number |
Z-0369-05 |
Recall Event ID |
30569 |
510(K)Number |
K931071 K981657
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Product Classification |
System, X-Ray, Stationary - Product Code KPR
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Product |
Thoravision 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. |
Recalling Firm/ Manufacturer |
Philips Medical Systems Sales & Service Region No. America 22100 Bothell Everett Hwy Bothell WA 98021
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For Additional Information Contact |
Sarah Baxter 425-487-7665
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Manufacturer Reason for Recall |
X-Ray system may fall downward and could possibly hit the patient.
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FDA Determined Cause 2 |
Other |
Action |
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. |
Quantity in Commerce |
44 total units (Thoravision I and II) |
Distribution |
The firm distributed this product to hospitals and medical centers nationwide. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 510(K)s with Product Code = KPR and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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