CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
Prosound F75 or F75 The Hitachi Aloka Medical, Ltd recalled
Hitachi Aloka Medical is recalling Prosound F75 or F75 The Hitachi Aloka Medical, Ltd, distributed nationwide in the US. The recall was initiated on 11 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1696-2017
- FDA event ID
- 76763
- Recalling firm
- Hitachi Aloka Medical, Wallingford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jun 2014
- FDA classified
- 29 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jun 2014 | Recall initiated by company | |
| 29 Mar 2017 | Classified by FDA | +1022 days |
| 5 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Loosened monitor arm.
Product as listed by the FDA
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 Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications
Where it was distributed
Nationwide Distribution to PA, TX, FL, AZ, IN, OH
Questions about this recall
Why was it recalled?
Loosened monitor arm.
Which lots are affected?
Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894
Where was it sold?
Nationwide Distribution to PA, TX, FL, AZ, IN, OH
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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