Recall Z-0118-2019 ยท LLZ System, Image Processing, Radiological
AS Software, Inc.
AS-OBGYN Information System version 7.824.x
| Date | Sep 20, 2018 |
| Status | Terminated |
| Reason | Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system |
| Root cause | Device Design |
| Action | AS Software issued letter by email on 9/20/18 to notify customers that any change made to their ultrasound machine such as software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, are tested prior to the use in the production environment. Medical Device Correction Return Response form to be signed and returned. The AS Software Support Department can be reached Monday through Friday, 9:00 AM to 6:00 PM EST via phone: 201-541-1900 option 2 or e-mail: info@as-software.com |
| Quantity | 52 systems |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051639 | AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM As Software, Inc., Aug 2, 2005 |