Z-1316-2008

Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and...

Name: Z-1316-2008 Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and...
Creator: Stryker Endoscopy
Published: 2008-02-15
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-02-15 / Terminated / root cause: software

FDA source

Stryker Endoscopy began a recall of Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system on 2008-02-15. The reason FDA records is "Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1316-2008
Status: Terminated
Initiated: 2008-02-15
Posted: 2008-09-11
Terminated: 2011-02-15
Recalling firm: Stryker Corp.
Product: Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.
Product code: LMB Device, Digital Image Storage, Radiological
Reason for recall: Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.
Root cause tag: software
FDA root cause: Software design
Action: Stryker Endoscopy mailed Urgent Device Correction notices, dated February 14, 2008, to all consignees, and sales representatives will be supplied with a fix to distribute to the user base.
Quantity in commerce: 814 units distributed
Distribution: Worldwide distribution: USA, Canada, Greece, and Germany.
Product codes and lots: Serial numbers 07H041654 - 08A069464, PP1.04

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)