Z-1445-2020Class II

Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900...

Name: Z-1445-2020 Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900...
Creator: Stryker Corporation
Published: 2019-04-23
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-04-23 / Terminated / root cause: manufacturing process

FDA source

Stryker Corporation began a recall of 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 -... on 2019-04-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1445-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-23
Posted: 2020-03-05
Terminated: 2021-06-03
Recalling firm: Stryker Corp.
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.
Product code: BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)
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.
Root cause tag: manufacturing process
FDA 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 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 [email protected]
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.
Product codes and lots: UDI: 07613327462784 Lot Numbers: 2019AN00005, 2019AN 00007, 2019AN00017, 2019AN00039, 2019AN00041, 2019AN00046, 2019AN00048, 2019AN00054, 2019AN00061, 2019AN00067, 2019AN00085, 2019AN00087

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1445-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1445-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-05

Product code BZN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)