DigitalDiagnost Single Detector (Stitching Patient Support) 712020

FDA Device Recall #Z-2863-2018 — Class II — June 27, 2018

Recall Summary

Recall Number Z-2863-2018
Classification Class II — Moderate risk
Date Initiated June 27, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems Gmbh, DMC
Location Hamburg
Product Type Devices

Product Description

DigitalDiagnost Single Detector (Stitching Patient Support) 712020

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.

Distribution Pattern

US Nationwide; International to 66 countries

Lot / Code Information

Serial Numbers: 399921/SN08000023 410038/SN08000091 402577/SN09000137 479651/SN11000391 443237/SN09000411 496881/SN12000104 489345/SN11000590 459498/SN10000231 483525/SN11000377 468302/SN10000537 485692/SN11000443 422533/SN09000072 450553/SN10000089 414087/SN08000100 472611/SN11000056 443235/SN09000450 481036/SN11000471 471070/SN10000695 471047/SN10000700 455221/SN10000251 460072/SN10000336 478109/SN11000327 475856/SN11000315 415754/SN08000063 443660/SN10000010 440700/SN10000030 440260/SN09000350 447603/SN09000468 448647/SN10000111 467487/SN11000085 467484/SN10000602 477526/SN11000311 490997/SN12000106 451267/SN10000104 445433/SN09000434 488711/SN11000615 470906/SN11000142 485620/SN12000002 448671/SN10000076 480052/SN11000286 480053/SN11000288 439920/SN09000329 412942/SN08000036 418438/SN08000110 431111/SN09000237

Other Recalls from Philips Medical Systems Gmbh, DMC

Recall # Classification Product Date
Z-2357-2021 Class II CombiDiagnost R90 Software Version R1.0 and R1.1 Jul 22, 2020
Z-1328-2020 Class II CombiDiagnost GCF, Software v. 1.0.5, Product C... Dec 19, 2019
Z-1329-2020 Class II CombiDiagnost PCF, Software v. 1.0.5, Product C... Dec 19, 2019
Z-0612-2019 Class II Stationary Fluoroscopic X-ray System CombiDiagn... Nov 7, 2018
Z-0239-2019 Class II Philips DigitalDiagnost software 4.1.x and 4.2.... Sep 19, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.