DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
FDA Device Recall #Z-2851-2018 — Class II — June 27, 2018
Recall Summary
| Recall Number | Z-2851-2018 |
| 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 High Performance (Stitching Patient Support) 712027
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: SN17000294 SN17000295 SN17000114 SN17000185 SN17000362 SN17000263 SN17000264 SN17000399 SN15000017 SN17000235 SN18000001 SN17000414 SN17000376 SN16000352 SN17000311 SN17000070 SN14000079 SN14000080 SN17000044 SN17000346 SN14000052 SN17000045 SN17000351 SN17000038 SN17000262 SN17000126 SN15000122 SN17000100 SN17000422 SN17000359 SN16000390 SN15000048 SN17000084 SN16000386 SN17000106 SN17000288 SN17000278 SN17000335 SN16000394 SN16000387 SN17000151 SN17000352 SN17000329 SN17000349 SN17000303 SN17000334 SN17000216 SN17000305 SN17000398 SN15000328 SN17000289 SN17000411 SN17000436 SN17000090 SN15000006 SN17000179 SN17000034 SN17000231 SN16000355 SN17000166 SN17000127 SN16000421 SN16000398 SN14000105 SN16000430 SN16000418 SN17000150 SN17000092 SN15000054 SN15000097 SN15000110 SN17000373 SN15000132 SN14000040 SN14000045 SN15000098 SN16000435 SN15000142 SN15000151 SN17000141 SN15000410 SN15000417 SN16000402
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.