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Class 2 Device Recall Mobile Digital Diagnostic XRay System |
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Date Initiated by Firm |
May 23, 2023 |
Date Posted |
June 30, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2045-2023 |
Recall Event ID |
92464 |
510(K)Number |
K191813
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Product Classification |
System, x-ray, mobile - Product Code IZL
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Product |
wDR 2.2 Mobile Digital Diagnostic X-Ray System |
Code Information |
Model MobileDiagnost wDR:
1) Model Number 712007, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3
2) Model Number 712006, Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3
3) Model Number 712004, Software version 2.1 with Windows 10 Upgrade
4) Model Number 712002, Software version 2.1 with Windows 10 Upgrade |
Recalling Firm/ Manufacturer |
SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain
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For Additional Information Contact |
847394-6960
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Manufacturer Reason for Recall |
There is a software login in issue that may prevent the user from logging in.
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FDA Determined Cause 2 |
Software change control |
Action |
A recall notification letter was mailed to customers in the United States by the US distributor, Philips, beginning May 23, 2023. Customers are advised to take the following actions:
1) To prevent the system from becoming inoperable, do not reboot or log out of your system until Philips has implemented the software correction.
2) Circulate this notice to all users of the device so that they are aware of the issue.
3) Complete and return the response form to Philips promptly and no later than 30 days from receipt.
A Philips representative will contact consignees to schedule a time for a Field Service Engineer to visit the site and implement a software solution to resolve the issue. |
Quantity in Commerce |
1061 units |
Distribution |
Distribution throughout United States including Puerto Rico and US Virgin Islands
OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Hungary, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia,Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal,
Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Zambia
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = IZL and Original Applicant = Sedecal SA
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