Device recall
Z-1696-2017: Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for…
FDA device recall · Class II · Hitachi Aloka Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-1696-2017 |
|---|---|
| Recall event | 76763 |
| Product | Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal… |
| Product code | IYN |
| Recalling firm | Hitachi Aloka Medical, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2017 |
| 510(k) numbers | K123828 |
| FEI number | 1000120865 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database