Exeter, N/A, United Kingdom
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE recalls
1 recall recorded since 2018, most recently on 4 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 4 June 2021
- Terminated
- 29 September 2022
- Reason
- A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data
- Distribution
- US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2253-2021, Z-2254-2021
- Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
- Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.