Class 3 Device Recall CDLCAM, Onepass Nuclear Medicine Imaging System

• Date Initiated by Firm: January 16, 2004
• Date Posted: February 10, 2004
• Recall Status: Terminated on April 12, 2012
• Recall Number: Z-0527-04
• Recall Event ID: 28161
• 510(K)Number: K023373
• Product Classification: Camera, Scintillation (Gamma) - Product Code IYX
• Product: CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
• Code Information: S/Ns: 100 thur 105, and 107 thru 116.
• FEI Number: 3003917438
• Recalling Firm/ Manufacturer: GVI Technology Partners; 1470 Enterprise Pkwy; Twinsburg OH 44087-2242
• For Additional Information Contact: 330-963-4083
• Manufacturer Reason for Recall: Due to limitations in the operating software, the acquired scan may not be processed properly.
• FDA Determined Cause: Other
• Action: The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit.
• Quantity in Commerce: 16 units
• Distribution: One Single customer.
• 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.

• 510(K) Database: 510(K)s with Product Code = IYX