Philips BuckyDiagnost Patient Support Material Recall for Footplate Safety
Philips Medical Systems is recalling BuckyDiagnost patient support materials because the footplate hook may fail, causing the plate to fall or swing and injure patients or operators.
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 physical injury to patients or operators from a falling or swinging footplate, but no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling Patient Support Material Number 9890 010 87431 used with BuckyDiagnost models 704060 and 706037. The recall involves 1,517 systems, though not all units are equipped with the specific patient support accessory. The affected patient support materials were distributed in the United States (MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY) and in Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
The recall is due to a defect where the hook does not securely hold the footplate in a vertical position. As a result, the footplate can fall or swing down, which may hurt the operator or patient. All patient support units intended for stitching are affected by this issue.
Healthcare facilities should stop using the affected patient support materials and contact Philips Medical Systems for instructions on how to proceed. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 1,517
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All patient support for stitching are affected.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems, 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.
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