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FDA (Device enforcement)Recalled 2019-04-23closedclass ii

Stryker Corporation: Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The

Is my product affected?

Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of minimally invasive and open

  • UPC 07613327462784

Check against the official notice below — it lists the full affected range.

What happened

Stryker Corporation is recalling 12 Stryker Connected OR Cart units (Model 120V, Ref Cat. #240-099-155) distributed worldwide, including locations in Georgia, Texas, Canada, Singapore, Thailand, and Malaysia. The carts were not manufactured to specifications, with the monitor positioned on the incorrect side of the monitor stow handle, preventing it from attaching flush as designed. This defect creates a risk that the monitor could fall from the monitor arm and injure users.

The recalled devices are identified by UDI 07613327462784 and can be found under lot numbers 2019AN00005, 2019AN00007, 2019AN00017, 2019AN00039, 2019AN00041, 2019AN00046, 2019AN00048, 2019AN00054, 2019AN00061, 2019AN00067, 2019AN00085, and 2019AN00087. The source document does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monitor arm and a risk of user injury.

Details from the source

Reason for recall: There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monitor arm and a risk of user injury. Distribution: Worldwide distribution - US Nationwide distribution in the states of GA, TX and countries of Canada, Singapore, Thailand, Malaysia. No US Govt. Quantity: 12 Devices Lot/code info: UDI: 07613327462784 Lot Numbers: 2019AN00005, 2019AN 00007, 2019AN00017, 2019AN00039, 2019AN00041, 2019AN00046, 2019AN00048, 2019AN00054, 2019AN00061, 2019AN00067, 2019AN00085, 2019AN00087

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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