Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Reported: August 18, 2021 Initiated: June 4, 2021 #Z-2254-2021
Product Description
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Reason for Recall
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
Details
- Recalling Firm
- Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
- Units Affected
- 6 software's
- Distribution
- US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
- Location
- Exeter, N/A
Frequently Asked Questions
What product was recalled? ▼
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.. Recalled by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE. Units affected: 6 software's.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2254-2021.
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