Philips BuckyDiagnost Radiographic Systems Recalled for Table Height Defects
Philips Healthcare is recalling 116 BuckyDiagnost radiographic systems because table height measurements were found out of specification, potentially causing system mis-alignment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (radiographic system mis-alignment) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Philips Healthcare Inc. is recalling 116 units of the Philips BuckyDiagnost Radiographic system, used for making diagnostic x-ray exposures. The affected catalog numbers are 704031, 704032, 704035, 704060, and 704062. The recall covers units distributed nationwide in the United States and in Canada.
The recall was initiated after an inspection of Installation Acceptance Test Document (IATD) and Source Image Distance (SID) records revealed that table height measurements were out of specification. This defect has the consequence of potential system mis-alignment. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities and consumers with these specific serial numbers should contact Philips Healthcare Inc. for further instructions on how to address the defect. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Philips BuckyDiagnost Radiographic. 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
- 116
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
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Same hazard · mis alignment
See all →- LowPhilips Diagnost Stationary Radiographic System Recalled for Table Height Non-Compliance
FDA (Devices) · 2013-06-26
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