Class 2 Device Recall Thoravision II

• Date Initiated by Firm: December 01, 2004
• Date Posted: December 24, 2004
• Recall Status: Terminated on February 10, 2006
• Recall Number: Z-0370-05
• Recall Event ID: 30569
• Product Classification: System, X-Ray, Stationary - Product Code KPR
• Product: Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812.
• Code Information: See the site numbers listed for the Thoravision I. The listed site numbers include both Thoravision I and II products.
• FEI Number: 1000524572
• Recalling Firm/ Manufacturer: Philips Medical Systems Sales & Service Region No. America; 22100 Bothell Everett Hwy; Bothell WA 98021
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer Reason for Recall: X-Ray system may fall downward and could possibly hit the patient.
• FDA Determined Cause: 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

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.