DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052

FDA Device Recall #Z-2865-2018 — Class II — June 27, 2018

Recall Summary

Recall Number Z-2865-2018
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, Dual-Detector (Stitching Patient Support) 712052

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: 363679 404164/SN0802462 378830/SN0802004 341693 358494 359442 396571/SN0802311 359449 346075 382021/SN0802313 374374 404298/SN0802474 402570/SN0802420 373501 373500 382272/SN0802113 368428 382012/SN0702520 376667 356957 392502/SN0802179 407423/SN0802638 359767 368619 358641 357697 381998/SN0702488 413829/SN0802631 358320 400364/SN0802522 404166/SN0802441 356981 390272/SN0802364 390273/SN0802366 412482/SN0802683 348997 396576/SN0802233 372848 373508 383084/SN0802127

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.