The Recall Desk
HighFDA (Devices)·Z-0364-2016·Announced 2015-12-09

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.

What this means for you

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.
Category
Medical Device — Imaging Equipment
Hazard
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

Distributed in 11 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems, Inc.

See all →

Same hazard · falling object

See all →