Philips BuckyDiagnost Radiographic. 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: 334584 345869 349805 352617 375957/SN07000650 352645 355617 356954 363678 362217 362252 361021 364214 362429 361526 363545 363802 364816 366510 366090 367504 370290 370643 373506 372845 376998 383090 384688/SN07000603 386397/SN07000659 406161/SN08000556 386265/SN08000415 389969/SN08000090 381103/SN08000131 444254/SN09000380 406491/SN08000315 389383/SN08000100 447038/SN10000169 389970/SN08000092 406017/SN08000307 389972/SN08000080 389656/SN08000052 386679/SN08000051 390255/SN08000050 394368/SN08000196 396406/SN08000193 399529/SN08000297 401268/SN08000268 402249/SN08000323 399571/SN08000559 384510/SN07000618 402246/SN08000261 403330/SN08000296 403648/SN08000292 407890/SN08000377 405887/SN08000381 413307/SN08000521 413205/SN08000562 411311/SN08000528 419318/SN09000042 428504/SN09000200 413818/SN08000526 414461/SN08000518 414601/SN08000501 438511/SN10000166 414315/SN08000474 418205/SN08000568 419316/SN09000007 421970/SN09000058 422097/SN09000068 426137/SN09000109 430918/SN09000175 435194/SN09000234 439546/SN09000334 439739/SN09000346 436337/SN09000251 438835/SN09000295 439098/SN09000294 439817/SN09000318 443072/SN09000363 443231/SN09000368 442855/SN09000357 443453/SN09000378 456506/SN10000167 449719/SN10000034 448152/SN10000013 448150/SN10000072 449717/SN10000068 450554/SN10000096 451156/SN10000059 456283/SN10000272 456082/SN10000174 458580/SN10000196 459495/SN10000212 460074/SN10000260 460485/SN10000228 460757/SN10000290 461677/SN10000302 461229/SN10000218 462389/SN10000252 463385/SN10000344 465974/SN10000320 468064/SN10000347 466164/SN10000336 468078/SN11000032 468518/SN10000353 470291/SN10000374 471046/SN10000386 471701/SN11000054 483054/SN11000246 476276/SN11000045 480210/SN11000126 483867/SN11000298 483244/SN11000199 486144/SN11000217 488176/SN11000244
  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 of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment
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. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics

Product Codes/Lot Numbers:

Serial Numbers: 334584 345869 349805 352617 375957/SN07000650 352645 355617 356954 363678 362217 362252 361021 364214 362429 361526 363545 363802 364816 366510 366090 367504 370290 370643 373506 372845 376998 383090 384688/SN07000603 386397/SN07000659 406161/SN08000556 386265/SN08000415 389969/SN08000090 381103/SN08000131 444254/SN09000380 406491/SN08000315 389383/SN08000100 447038/SN10000169 389970/SN08000092 406017/SN08000307 389972/SN08000080 389656/SN08000052 386679/SN08000051 390255/SN08000050 394368/SN08000196 396406/SN08000193 399529/SN08000297 401268/SN08000268 402249/SN08000323 399571/SN08000559 384510/SN07000618 402246/SN08000261 403330/SN08000296 403648/SN08000292 407890/SN08000377 405887/SN08000381 413307/SN08000521 413205/SN08000562 411311/SN08000528 419318/SN09000042 428504/SN09000200 413818/SN08000526 414461/SN08000518 414601/SN08000501 438511/SN10000166 414315/SN08000474 418205/SN08000568 419316/SN09000007 421970/SN09000058 422097/SN09000068 426137/SN09000109 430918/SN09000175 435194/SN09000234 439546/SN09000334 439739/SN09000346 436337/SN09000251 438835/SN09000295 439098/SN09000294 439817/SN09000318 443072/SN09000363 443231/SN09000368 442855/SN09000357 443453/SN09000378 456506/SN10000167 449719/SN10000034 448152/SN10000013 448150/SN10000072 449717/SN10000068 450554/SN10000096 451156/SN10000059 456283/SN10000272 456082/SN10000174 458580/SN10000196 459495/SN10000212 460074/SN10000260 460485/SN10000228 460757/SN10000290 461677/SN10000302 461229/SN10000218 462389/SN10000252 463385/SN10000344 465974/SN10000320 468064/SN10000347 466164/SN10000336 468078/SN11000032 468518/SN10000353 470291/SN10000374 471046/SN10000386 471701/SN11000054 483054/SN11000246 476276/SN11000045 480210/SN11000126 483867/SN11000298 483244/SN11000199 486144/SN11000217 488176/SN11000244

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1450-2013

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 →