CLASS II Device recall · Reported 26 Jun 2013 · FDA Enforcement Report
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system recalled
Philips Healthcare is recalling Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system, distributed nationwide in the US. The recall was initiated on 16 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1449-2013
- FDA event ID
- 64128
- Recalling firm
- Philips Healthcare, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2013
- FDA classified
- 17 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Imaging Equipment
Timeline
| 16 Jan 2013 | Recall initiated by company | |
| 17 Jun 2013 | Classified by FDA | +152 days |
| 26 Jun 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide and the country of Canada.
Questions about this recall
Is Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system recalled?
Yes. Philips Healthcare recalled Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system on 16 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-1449-2013.
Why was it recalled?
An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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