Class 2 Device Recall Philips DigitalDiagnost Release 3

• Date Initiated by Firm: June 27, 2018
• Date Posted: August 17, 2018
• Recall Status: Terminated on April 30, 2024
• Recall Number: Z-2861-2018
• Recall Event ID: 80577
• 510(K)Number: K090625
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• Product: DigitalDiagnost Release 3 (Stitching Patient Support) 712025
• Code Information: Serial Numbers: SN13000132 514201/SN12000334 SN13000145 485094/SN11000028 485093/SN11000029 SN13000150 498131/SN12000072 515567/SN12000365 SN13000186 SN13000227 SN13000280 514978/SN12000374 514917/SN12000338 520248/SN13000057 512305/SN12000296 499378/SN12000065 515647/SN12000361 SN13000162 SN13000322 SN13000388 SN13000440 518940/SN13000015 498389/SN12000046 SN13000419 SN13000183 497871/SN12000116 497872/SN12000123 SN13000170 493886/SN12000067 SN13000247 521377/SN13000113 512184/SN12000267 514540/SN12000384 514291/SN12000322 506687/SN12000184 506685/SN12000185 515888/SN12000342 515889/SN12000357 519026/SN13000028 514210/SN12000313 505513/SN12000302 519509/SN13000056 492928 515713/SN13000093 SN13000426 513549/SN12000332 504226/SN12000212 513792/SN12000295 SN13000260 514303/SN12000395 494356/SN12000005 515262/SN12000324 SN13000311 SN13000111 496399/SN12000118 496394/SN12000045 497058/SN12000030 518706/SN13000045 506258/SN12000152 519609/SN13000060 512167/SN13000097 SN13000342 504404/SN12000223 519329/SN13000044 SN13000265 192929/SN11000055 SN13000447 SN13000366 SN13000456 504665/SN12000213 521255/SN13000104 491790/SN11000073 495027/SN12000034 517758/SN12000389 SN13000341 SN13000314 504769/SN12000214 488603/SN11000063 489349/SN11000067 514290/SN13000013 512235/SN12000289 SN13000176 515464/SN12000327 491708/SN12000001 497889/SN12000106 492192/SN12000028 SN13000336 SN13000143 499759/SN12000080 503540/SN12000197
• Recalling Firm/ Manufacturer: Philips Medical Systems Gmbh, DMC; Development And Manufacturing Ctr.; Rontgenstr. 24; Hamburg Germany
• For Additional Information Contact: Philips Service Engineer; 40-50782110
• Manufacturer Reason for Recall: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
• FDA Determined Cause: Device Design
• Action: On June 27, 2018, Philips Medical Systems issued URGENT FIELD SAFETY NOTICES, Medical Device Recall letters to customers. Customers were encouraged to always check the right position of the hook and ensure that the hook is locked according tot he IFU. Press hook down until it is locked. Make sure that the hook is in position. A Philips Service Engineer will contact impacted customers as soon as the Field Action Kit is ready to be implemented. Should you need to communicate with Philips in regards to this program, please reference FCO-71200185. If you need further information or support concerning this issue, please contact your local Philips representative.
• Distribution: US Nationwide; International to 66 countries
• 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 = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.