Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 248244 351896 304009 347726 340184 353318 316236 357275 356983 325939 325940 602603 702009 348997 362251 356153 356131 351083 356334 355648 355646 354256 355644 356526 362438 7212356 359439 357888 355621 370816 357413 367356 358322 363680 358494 7000281 363670 703465 363671 367771 375952 365956 372485 372486 369545 70700 372973 374374 375370 380750/SN0702498 385560/SN0802190 401126/SN0802540 396834/SN0802370 414494/SN0802648 429753/SN0902090 434680/SN0902161 379200/SN0802088 390276/SN0802289 390109/SN0802396 383893/SN0802238 419661/SN0902011 402570/SN0802420 425721/SN0902102 414495/SN0802649 381879/SN0802058 384511/SN0802050 384779/SN0802164 410916/SN0802636 392486/SN0802181 434675/SN1002002 427612/SN0902122 389101/SN0802194 384033/SN0802219 392505/SN0802162 392504/SN0802182 382164/SN0802018 367618 396576/SN0802233 427616/SN0902145 428232/SN0902049 415314/SN0902058 396197/SN0802210 445433/SN09000434 398178/SN0802348 427504/SN0902048 399555/SN0802572 422534/SN0902027 399153/SN0802347 422101/SN0902030 412482/SN0802683 404166/SN0802441 402844/SN0802432 402853/SN0902012 405687/SN0802469 404164/SN0802462 404459/SN0802468 407425/SN08000031 418438/SN08000110 409702/SN0802557 435537/SN0902144 408200/SN0802520 409461 414931/SN0902033 412678/SN0802695 410040/SN08000021 410038/SN08000091 410039/SN08000093 423259/SN09000074 422832/SN09000061 412921/SN0802657 427610/SN0902108 433651/SN0902114 413845/SN09000004 415626/SN08000067 416651/SN08000086 422535/SN09020032 437764/SN09000292 421977/SN09000115 455753/SN10000432 455225/SN11000051 423037/SN09000153 421032/SN09000063 421034/SN09000041 427226/SN09000209 428241/SN09000220 435420/SN09000263 441921/SN09000431 440260/SN09000350 430355/SN09000214 441778/SN09000452 440249/SN09000347 439032/SN09000305 440692/SN09000443 444627/SN10000142 442306/SN10000177 442310/SN10000149 442129/SN10000171 442235/SN10000160 455550/SN10000364 461799/SN10000347 446047/SN09000440 449718/SN10000093 446665/SN09000451 461979/SN10000701 461976/SN10000704 456093/SN10000204 453385/SN10000383 451543/SN10000100 451542/SN10000098 445533/SN10000006 456179/SN10000274 487800/SN11000531 455752/SN10000200 456282/SN10000271 459772/SN10000294 463799/SN10000400 464863/SN10000533 463407/SN10000395 464755/SN10000391 472611/SN11000056 466808/SN10000464 464981/SN10000471 471148/SN11000122 471147/SN11000120 469133/SN10000572 469559/SN10000592 473817/SN11000108 477209/SN11000148 475235/SN11000119 471047/SN10000700 471066/SN10000696 471070/SN10000695 474089/SN11000079 479766/SN11000234 487719/SN11000538
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Installation Acceptance Test Document (IATD) non compliant with regulations 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 Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Product Codes/Lot Numbers:
Serial Numbers: 248244 351896 304009 347726 340184 353318 316236 357275 356983 325939 325940 602603 702009 348997 362251 356153 356131 351083 356334 355648 355646 354256 355644 356526 362438 7212356 359439 357888 355621 370816 357413 367356 358322 363680 358494 7000281 363670 703465 363671 367771 375952 365956 372485 372486 369545 70700 372973 374374 375370 380750/SN0702498 385560/SN0802190 401126/SN0802540 396834/SN0802370 414494/SN0802648 429753/SN0902090 434680/SN0902161 379200/SN0802088 390276/SN0802289 390109/SN0802396 383893/SN0802238 419661/SN0902011 402570/SN0802420 425721/SN0902102 414495/SN0802649 381879/SN0802058 384511/SN0802050 384779/SN0802164 410916/SN0802636 392486/SN0802181 434675/SN1002002 427612/SN0902122 389101/SN0802194 384033/SN0802219 392505/SN0802162 392504/SN0802182 382164/SN0802018 367618 396576/SN0802233 427616/SN0902145 428232/SN0902049 415314/SN0902058 396197/SN0802210 445433/SN09000434 398178/SN0802348 427504/SN0902048 399555/SN0802572 422534/SN0902027 399153/SN0802347 422101/SN0902030 412482/SN0802683 404166/SN0802441 402844/SN0802432 402853/SN0902012 405687/SN0802469 404164/SN0802462 404459/SN0802468 407425/SN08000031 418438/SN08000110 409702/SN0802557 435537/SN0902144 408200/SN0802520 409461 414931/SN0902033 412678/SN0802695 410040/SN08000021 410038/SN08000091 410039/SN08000093 423259/SN09000074 422832/SN09000061 412921/SN0802657 427610/SN0902108 433651/SN0902114 413845/SN09000004 415626/SN08000067 416651/SN08000086 422535/SN09020032 437764/SN09000292 421977/SN09000115 455753/SN10000432 455225/SN11000051 423037/SN09000153 421032/SN09000063 421034/SN09000041 427226/SN09000209 428241/SN09000220 435420/SN09000263 441921/SN09000431 440260/SN09000350 430355/SN09000214 441778/SN09000452 440249/SN09000347 439032/SN09000305 440692/SN09000443 444627/SN10000142 442306/SN10000177 442310/SN10000149 442129/SN10000171 442235/SN10000160 455550/SN10000364 461799/SN10000347 446047/SN09000440 449718/SN10000093 446665/SN09000451 461979/SN10000701 461976/SN10000704 456093/SN10000204 453385/SN10000383 451543/SN10000100 451542/SN10000098 445533/SN10000006 456179/SN10000274 487800/SN11000531 455752/SN10000200 456282/SN10000271 459772/SN10000294 463799/SN10000400 464863/SN10000533 463407/SN10000395 464755/SN10000391 472611/SN11000056 466808/SN10000464 464981/SN10000471 471148/SN11000122 471147/SN11000120 469133/SN10000572 469559/SN10000592 473817/SN11000108 477209/SN11000148 475235/SN11000119 471047/SN10000700 471066/SN10000696 471070/SN10000695 474089/SN11000079 479766/SN11000234 487719/SN11000538
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1447-2013
Related Recalls
Incisive CT, software version 5.0
Philips Healthcare
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.
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Philips Healthcare
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.
Azurion systems with software release R2.0.x
Philips Healthcare
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.