Philips BuckyDiagnost Radiographic X-ray System Recalled for Documentation Issues
Philips Healthcare Inc. is recalling 66 BuckyDiagnost Radiographic X-ray systems because installation acceptance test documentation was missing or inconsistent.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves documentation issues (missing or inconsistent installation acceptance test records) with no reported injuries, illnesses, or deaths, and the hazard is administrative rather than a direct physical safety risk.
Plain-English summary
Philips Healthcare Inc. is recalling 66 units of the BuckyDiagnost Radiographic Diagnostic X-ray system. The affected units are identified by specific catalog numbers (704031, 704032, 704035, 704060, 704062) and a list of serial numbers provided in the recall notice. These systems are used for making diagnostic x-ray exposures.
The recall was initiated after an inspection revealed that Installation Acceptance Test (IAT) documentation could not be located for several units, or that different templates had been used for the tests. This indicates a documentation and quality control issue regarding the verification of the equipment's installation.
The affected units were distributed nationwide in the United States and in Canada. No illnesses, injuries, or deaths have been reported in connection with this recall. Healthcare facilities should contact Philips Healthcare Inc. for further instructions on how to resolve the documentation issues.
The recalled product
- Product
- 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.
- Manufacturer
- Philips Healthcare Inc.
- Hazard
- Affected units
- 66
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Healthcare Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Philips Healthcare Inc.
See all →- ModeratePhilips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
FDA (Devices) · 2017-04-12
- HighPhilips IntellVue Info Center Patient Monitor Recall for Reboot Loop
FDA (Devices) · 2014-06-18
- ModeratePhilips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation
FDA (Devices) · 2013-09-04
- LowPhilips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use
FDA (Devices) · 2013-08-28
- ModeratePhilips IntelliVue Smart-hopping 1.4 GHz Access Point Recalled for Signal Loss
FDA (Devices) · 2013-07-31
Same hazard · documentation issue
See all →- LowBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa 350010 series recalled for lacking unique device identifier
FDA (Devices) · 2026-03-18
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18