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

FDA device recall Z-0867-2011 · posted 2011-01-07 · Terminated

Recall details

Recalling firm

Stryker Endoscopy

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LMD

Quantity affected

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

Date initiated

2009-12-11

Date posted

2011-01-07

Date terminated

2011-01-08

Location

San Jose, CA