device · product 1 of 1
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.
- Recall number
- Z-1445-2020
- Initiated
- April 23, 2019
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Stryker Corporation
- Quantity
- 12 Devices
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
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.
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.