Class 2 Device Recall Stryker Connected OR Cart,120 V Ref Cat. 240099155

• Date Initiated by Firm: April 23, 2019
• Create Date: March 05, 2020
• Recall Status: Terminated on June 03, 2021
• Recall Number: Z-1445-2020
• Recall Event ID: 84715
• Product Classification: Cart, emergency, cardiopulmonary (excluding equipment) - Product Code BZN
• 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.
• Code Information: UDI: 07613327462784 Lot Numbers: 2019AN00005, 2019AN 00007, 2019AN00017, 2019AN00039, 2019AN00041, 2019AN00046, 2019AN00048, 2019AN00054, 2019AN00061, 2019AN00067, 2019AN00085, 2019AN00087
• Recalling Firm/ Manufacturer: Stryker Corporation; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Valerie Estrada; 408-754-2000
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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
• Quantity in Commerce: 12 Devices
• Distribution: Worldwide distribution - US Nationwide distribution in the states of GA, TX and countries of Canada, Singapore, Thailand, Malaysia. No US Govt.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.