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Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detec...

FDA Device Recall #Z-2465-2012 — Class II — September 6, 2012

Recall Summary

Recall Number Z-2465-2012
Classification Class II — Moderate risk
Date Initiated September 6, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Healthcare Inc.
Location Andover, MA
Product Type Devices
Quantity 93 Units

Product Description

Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.

Reason for Recall

The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down

Distribution Pattern

Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom.

Lot / Code Information

Serial Numbers: SN10000053 SN11000644 SN10000648 SN10000649 SN11000226 SN10000703 SN11000032 SN10000407 SN11000105 SN11000112 SN11000212 SN11000231 SN11000030 SN10000468 SN11000146 SN11000217 SN11000238 SN11000407 SN11000154 SN10000297 SN10000515 SN11000129 SN11000266 SN11000412 SN11000442 SN11000063 SN11000441 SN10000416 SN10000414 SN10000424 SN11000034 SN10000018 SN11000050 SN10000113 SN10000442 SN11000057 SN11000419 SN10000482 SN10000670 SN10000690 SN10000689 SN10000694 SN11000461 SN10000544 SN11000095 SN11000329 SN11000464 SN10000554 SN10000635 SN10000107 SN10000413 SN10000557 SN11000092 SN11000100 SN11000118 SN11000145 SN11000161 SN11000193 SN11000194 SN11000228 SN11000294 SN11000371 SN10000038 SN10000101 SN10000102 SN10000641 SN10000664 SN11000027 SN10000537 SN10000650 SN11000130 SN11000142 SN11000216 SN11000269 SN11000286 SN11000288 SN11000311 SN11000320 SN10000363 SN10000246 SN10000512 SN11000033 SN11000053 SN11000080 SN11000271 SN11000478 SN11000474 SN11000013 SN11000005 SN11000008 SN11000004 SN11000141 SN11000007

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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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