—#179102

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.

FDA product code: BZN — Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: UDI: 07613327462784 Lot Numbers: 2019AN00005, 2019AN 00007, 2019AN00017, 2019AN00039, 2019AN00041, 2019AN00046, 2019AN00048, 2019AN00054, 2019AN00061, 2019AN00067, 2019AN00085, 2019AN00087

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 04/23/2019, the firm send an "Urgent Medical Device Recall Notification" to its domestic customers via certified mail with tracking information, to inform them the firm has become aware there is a potential problem with its medical device. This recall has affected 12 units that have a serial number listed in the letter. The firm is instructing its customers/users to take the following actions: 1. Inform individuals within their organization who need to be aware of this device recall. 2. Check all stock areas, operating rooms and/or operating room storage to determine if any devices from the affected product list are at their facility. Response is required by May 31, 2019. 3. If they received the affected part number (0240-099-155), the local Endoscopy Sales Representative will be in contact to determine if they are affected by this recall. The firm is requesting to forward a copy of this letter to any other personnel within their facility that they deem appropriate. Please send any questions to endorecall@stryker.com

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

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

Timeline

Recall initiated: 2019-04-23
Terminated: 2021-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179102. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.