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Class 2 Device Recall Stryker Digital Capture Pro 2 |
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Date Initiated by Firm |
December 11, 2009 |
Date Posted |
January 07, 2011 |
Recall Status1 |
Terminated 3 on January 08, 2011 |
Recall Number |
Z-0867-2011 |
Recall Event ID |
54651 |
Product Classification |
System, digital image communications, radiological - Product Code LMD
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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 CA 95138-1400
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For Additional Information Contact |
Nila Patel 408-754-2108
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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
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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