Z-0867-2011

Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for...

Name: Z-0867-2011 Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for...
Creator: Stryker Endoscopy
Published: 2009-12-11
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-12-11 / Terminated / root cause: software

FDA source

Stryker Endoscopy began a recall of Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures... on 2009-12-11. The reason FDA records is "Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start from 1 Oct 2001 and begin incrementing...". 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-0867-2011
Status: Terminated
Initiated: 2009-12-11
Posted: 2011-01-07
Terminated: 2011-01-08
Recalling firm: Stryker Corp.
Product: Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA.
Product code: LMD System, Digital Image Communications, Radiological
Reason for recall: Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start from 1 Oct 2001 and begin incrementing from that point onwards. The system date will be incorrect and users will not be able to correct this issue. Problem will not affect how pictures or videos are captured using SDC Pro
Root cause tag: software
FDA root cause: Software design
Action: Stryker Endocoscopy sent an URGENT: Device Correction letter dated December 11, 2009, to the OR Supervisor/Risk Manager and all Stryker Sales Representatives. The letter identified the product, the problem, and the action to be taken by the Sales Representatives. Sales Representatives were to identify affected accounts. Go to customer accounts and install the upgrade for each affected unit. Upon completion of the upgrade, the sales rep was to sign the acknowledgment form indicating that all of their affected accounts received the appropriate software fix and mail to Stryker Endoscopy or fax both sides of the postcard to 408-754-8378 or scan in both sides of the postcard and email to [email protected]. For questions regarding this recall call 408-754-2738 or 408-754-2000.
Quantity in commerce: 3070 units
Distribution: Worldwide Distribution - USA including AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL IN, IA, KS, KY, LA, MA, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Africa, Australia, Brazil, Cnanda, China, France, Germany, Hong Kong, Iberia, Italy, Japan, Korea, Latin America, Mexico, Netherlands, Poland, Puerto Rico, Scandinavia, Singapore, Switzerland, Thailand, and the UK
Product codes and lots: Type: SDC Pro 2; Product Code: LMD, LMB; Model Number: 240-050-800 (CD Version) and 240-050-810 (DVD Version)

Product code LMD

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)