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Recall Observatory FDA recall evidence

Device product

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-field imaging systems such as the Stryker Advanced Imaging Modality (AIM) System, PINPOINT Endoscopic Fluorescence Imaging System, or SPY Portable Handled Imaging (SPY-PHI) System) during intraoperative use. The Cart also provides power, video, and data connections to the components.

Z-1445-2020

April 23, 2019

Class II

Product summary

Firm
Stryker Corporation
Event
Event 84715
Status
Terminated
Classification
Class II
Quantity
12 Devices
Official record key
device-enforcement:Z-1445-2020

Official wording

Reason: 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.

Code information: UDI: 07613327462784 Lot Numbers: 2019AN00005, 2019AN 00007, 2019AN00017, 2019AN00039, 2019AN00041, 2019AN00046, 2019AN00048, 2019AN00054, 2019AN00061, 2019AN00067, 2019AN00085, 2019AN00087

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of GA, TX and countries of Canada, Singapore, Thailand, Malaysia. No US Govt.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.