Philips EasyDiagnost Patient Support Material Recalled for Footplate Safety Hazard
Philips Medical Systems is recalling patient support materials for the EasyDiagnost device because the footplate hook may fail, causing the footplate to fall or swing and potentially 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 involves a risk-of-harm product where the footplate can fall or swing and may hurt the operator or patient, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling Patient Support Material Number 9890 010 87431, which is used with the EasyDiagnost Model 706050. The recall involves 260 units, though not all units are equipped with the patient support accessory. The affected materials were distributed in the United States (MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY) and internationally 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 the patient. All patient support for stitching are affected by this issue.
Healthcare facilities and users should stop using the affected patient support materials immediately. Philips Medical Systems is the recalling firm and is responsible for managing the recall actions.
The recalled product
- Product
- Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Patient Support
- Affected units
- 260
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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