DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

FDA Device Recall #Z-2855-2018 — Class II — June 27, 2018

Recall Summary

Recall Number Z-2855-2018
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 4.1 High Performance (Stitching Patient Support) 712031

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: SN15000291 SN16000158 SN15000374 SN15000298 SN16000191 SN15000327 SN17000317 SN16000321 SN16000063 SN15000364 SN15000444 SN16000143 SN15000443 SN16000037 SN15000371 SN15000303 SN16000137 SN16000329 SN16000095 SN16000308 SN16000328 SN16000043 SN16000151 SN15000442 SN16000147 SN16000146 SN16000050 SN16000271 SN16000253 SN16000073 SN16000296 SN16000297 SN16000311 SN16000263 SN16000371 SN16000214 SN16000142 SN16000025 SN16000165 SN16000105 SN15000264 SN16000264 SN16000302 SN16000113 SN16000112 SN16000123 SN15000373 SN15000165 SN16000347 SN16000375 SN15000355 SN16000225

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.