Recall Z-1445-2020 ยท BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)
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 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 Endoscop
| Date | Apr 23, 2019 |
| Status | Terminated |
| 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. |
| Root 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 |
| Quantity | 12 Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of GA, TX and countries of Canada, Singapore, Thailand, Malaysia. No US Govt. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.