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U.S. Department of Health and Human Services

Class 3 Device Recall Scanpoint Communication Cradles

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  Class 3 Device Recall Scanpoint Communication Cradles see related information
Date Initiated by Firm September 20, 2010
Date Posted October 26, 2010
Recall Status1 Terminated 3 on April 01, 2011
Recall Number Z-0143-2011
Recall Event ID 56790
510(K)Number K022153  K030763  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..."
Code Information Serial numbers:  CC012000, CC012001, CC012002, CC012003, CC012004, CC012005, CC012006, CC012007, CC012008, CC012009, CC012010, CC012011, CC012012, CC012013, CC012014, CC012016, CC012017, CC012018, CC012019, CC012020, CC012021, CC012022, CC012024, CC012026, CC012027, CC012028, CC012029, CC012030, CC012031, CC012032, CC012033, CC012034, CC012035, CC012036, CC012037, CC012038, CC012039, CC012040, CC012041, CC012042, CC012044, CC012045, CC012046, CC012049, CC012050, CC012052, CC012054, CC012055, CC012056, CC012057, CC012058, CC012059, CC012060, CC012061, CC012062, CC012063, CC012064, CC012065, CC012066, CC012067, CC012068, CC012069, CC012070, CC012071, CC012072, CC012075, CC012076, CC012080, CC012083, and CC012084.
Recalling Firm/
Manufacturer		 Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information Contact Verathon Customer Care
425-867-1348
Manufacturer Reason
for Recall		 Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect the transfer of exams and device calibration through QuickPrint interface.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action On 09/20/10, Verathon issued an URGENT: Medical Device Accessory Recall Notification letter dated September 20, 2010 to consignees, identifying the affected product, the issue prompting the recall, and actions to be taken by consignees. The consignees are instructed to return any cradles within the serial number range between CC012000-CC012084, and the Part Number 0570-0168. The firm will provide a replacement communication cradle at no cost. Consignees can contact Verathon Customer Care at 425-867-1348 or 800-2331-2313 or send e-mail to cservice@verathon.com.
Quantity in Commerce 70 units
Distribution Worldwide Distribution: U.S. nationwide including states AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, ND, NY, OH, PA, SC, TN, TX, UT, WI, and Washington DC, and the countries of Australia, Canada, France, South Korea, Taiwan, The Netherlands, and United Kingdom.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = DIAGNOSTIC ULTRASOUND CORP.
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