Date Initiated by Firm |
March 22, 2017 |
Create Date |
April 14, 2017 |
Recall Status1 |
Terminated 3 on May 17, 2021 |
Recall Number |
Z-1822-2017 |
Recall Event ID |
76810 |
510(K)Number |
K041949 K031333 K033737 K102005
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; Allura Xper FD20 722012; Allura Xper FD20 biplane 722013; Allura Xper FD10 OR Table 722014; Allura Xper FD20 OR Table 722015; Allura Xper FD10/10 OR Table 722019; Allura Xper FD20 Biplane OR Table 722020; Allura Xper FD10 OR Table 722022; Allura Xper FD20 OR Table 722023; Allura Xper FD10/10 OR Table 722024; Allura Xper FD20 Biplane OR Table 722025; Allura CV20 722031
|
Code Information |
Devices with a Laird Chiller. |
Recalling Firm/ Manufacturer |
Philips Electronics North America Corporation 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
800-722-9377
|
Manufacturer Reason for Recall |
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips. |
Quantity in Commerce |
6992 (total distributed for all products) |
Distribution |
Nationwide, worldwide including Canada |
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.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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