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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Digital Capture Pro 2

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 Class 2 Recall
Stryker Digital Capture Pro 2
see related information
Date Posted January 07, 2011
Recall Status1 Terminated on January 08, 2011
Recall Number Z-0867-2011
Recall Event ID 54651
Product Classification System, Digital Image Communications, Radiological - Product Code LMD
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.
Code Information Type: SDC Pro 2; Product Code: LMD, LMB; Model Number: 240-050-800 (CD Version) and 240-050-810 (DVD Version)
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
For Additional Information Contact Nila Patel
408-754-2108
Manufacturer 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
FDA Determined
Cause 2
DESIGN: 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 sdcpro2recall@stryker.com. 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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