Recall Z-0232-04 ยท MAA Monitor, Fetal Doppler Ultrasound
Danatech Medical Systems Inc
Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.
| Date | Jul 20, 2004 (initiated Dec 5, 2003) |
| Status | Terminated |
| Reason | This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet. |
| Root cause | Other |
| Action | The firm mailed via overnight priority mail, a recall notification letter with response form to consignees on 12/5/2003 requesting return of the product and refund. |
| Quantity | 89 units |
| Distribution | Product was distributed to 89 consumers nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.