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DigitalDiagnost Release 3 (Stitching Patient Support) 712025

FDA Device Recall #Z-2861-2018 — Class II — June 27, 2018

Recall Summary

Recall Number Z-2861-2018
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 Release 3 (Stitching Patient Support) 712025

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: 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

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.

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