The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No
FDA device recall Z-0143-2011 · posted 2010-10-26 · Terminated
Recall details
- Recalling firm
- Verathon, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 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 countrie
- Date initiated
- 2010-09-20
- Date posted
- 2010-10-26
- Date terminated
- 2011-04-01
- Location
- Bothell, WA
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