Z-0143-2011

The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking...

Name: Z-0143-2011 The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking...
Creator: Verathon, Inc.
Published: 2010-09-20
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2010-09-20 / Terminated / root cause: software

FDA source

Verathon, Inc. began a recall of The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..." on 2010-09-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0143-2011
Status: Terminated
Initiated: 2010-09-20
Posted: 2010-10-26
Terminated: 2011-04-01
Recalling firm: Verathon Inc.
Product: The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..."
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: software
FDA root cause: 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 [email protected].
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.
Product codes and lots: 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.

Product code ITX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)