The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..."
This recall has been terminated (originally issued October 26, 2010).
- Company
- Verathon, Inc.
- Recall Initiated
- September 20, 2010
- Posted
- October 26, 2010
- Terminated
- April 1, 2011
- Recall Number
- Z-0143-2011
- Quantity
- 70 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Software design (manufacturing process)
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.