Z-1590-2010

An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to...

Name: Z-1590-2010 An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to...
Creator: Stryker Endoscopy
Published: 2009-10-23
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-10-23 / Terminated / root cause: design

FDA source

Stryker Endoscopy began a recall of An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the... on 2009-10-23. The reason FDA records is "Video device is not able to assign the correct time/date stamp". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1590-2010
Status: Terminated
Initiated: 2009-10-23
Posted: 2010-05-10
Terminated: 2011-02-17
Recalling firm: Stryker Corp.
Product: An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be transferred to external media.
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Video device is not able to assign the correct time/date stamp.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Endoscopy has notified the 2865 domestic consignees affected by the device correction. The notification was mailed to affected consignees and their corresponding sales representatives. It included two mailings of the Urgent: Device Correction notice, SDC HD 3.0z correction software, and a SDC HD upgrade dongle. 100% of consignees have been contacted and notified of the device correction needed. The effectiveness of the correction has been tracked via acknowledgement cards mailed, faxed, or emailed. The local Stryker Sales Representative will install a software upgrade to fix this issue. Additional questions should be directed to the firm's Customer Service at (800)624-4422 or (408)754-2039.
Quantity in commerce: 12896 devices
Distribution: US government facilities and other US domestic consignees(nationwide), and to foreign countries
Product codes and lots: Product Name: SDC HD units and SDC HDi units Model Nuumbers: 240-050-888 and 240-050-888i Code: All SDC HD and SDC HDi units

Product code LMB

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)