Stryker Vision Mounting Arm Recalled Due to Display Detachment Risk
Stryker Endoscopy is recalling 14,271 Vision Mounting Arms because excessive force can cause the display to detach and fall on users or patients.
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 display can fall on a user or patient, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria.
Plain-English summary
Stryker Endoscopy is recalling 14,271 units of the Stryker Vision Mounting Arm, model number 0240-095-200. This medical device is used in surgical operating rooms to hold and position LCD monitors for Stryker Endoscopy products. The recall covers all serial numbers of this model.
The recall was initiated because it is possible for a user to apply excessive force when positioning the display on the video cart, which can push the display up and out of the mounting arm. This failure mode can result in the display falling upon the user or patient. The product was distributed worldwide, including the United States and various international locations.
Healthcare facilities should stop using the affected mounting arms and contact Stryker Endoscopy for instructions on how to proceed with the recall.
The recalled product
- Product
- Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The…
- Manufacturer
- Stryker Endoscopy
- Affected units
- 14,271
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 (2)
- Model number 0240-095-200
- all serial numbers.
Distribution
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