Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 335292 351085 351326 348891 348895 353313 358016 359426 370503 354382 354749 369640 380748 356820 362256 357699 362257 357255 358489 380361 363543 362719 363669 363544 363305 363538 365150 364211 379698 380749 375725 375727 375729 377144 381880 381881 380798/SN07000617 381877 383767/SN07000639 392883/SN08000099 394519/SN08000135 421035/SN09000031 396577/SN08000190 402575/SN08000382 397513/SN08000185 407681/SN08000345 411751/SN08000438 410786/SN08000454 417251/SN08000547 427833/SN09000208 415998/SN08000511 416000/SN08000508 421979/SN09000098 422100/SN09000216 442036/SN09000336 448226/SN09000416 455130/SN10000286 462191/SN10000266 468071/SN10000398 467831/SN10000326 471707/SN11000023 477922/SN11000076 481951/SN11000205 489697/SN11000261
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Healthcare Inc.
Reason for Recall:
An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.

Product Codes/Lot Numbers:

Serial Numbers: 335292 351085 351326 348891 348895 353313 358016 359426 370503 354382 354749 369640 380748 356820 362256 357699 362257 357255 358489 380361 363543 362719 363669 363544 363305 363538 365150 364211 379698 380749 375725 375727 375729 377144 381880 381881 380798/SN07000617 381877 383767/SN07000639 392883/SN08000099 394519/SN08000135 421035/SN09000031 396577/SN08000190 402575/SN08000382 397513/SN08000185 407681/SN08000345 411751/SN08000438 410786/SN08000454 417251/SN08000547 427833/SN09000208 415998/SN08000511 416000/SN08000508 421979/SN09000098 422100/SN09000216 442036/SN09000336 448226/SN09000416 455130/SN10000286 462191/SN10000266 468071/SN10000398 467831/SN10000326 471707/SN11000023 477922/SN11000076 481951/SN11000205 489697/SN11000261

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1449-2013

Related Recalls

Class I - Dangerous

Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.

Aug 2, 2023 Infusion Pumps Nationwide View Details →

Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.

Feb 2, 2022 Implants & Prosthetics Nationwide View Details →
Class I - Dangerous

In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

May 26, 2021 Other Medical Devices Nationwide View Details →