Recall Z-2253-2021— Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Class II · Terminated
Class II FDA medical device recall by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE, initiated 2021-06-04, terminated 2022-09-29. It names one FDA 510(k) clearance: K142779. Product: Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.. 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.
- Recalling firm
- Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-04
- Terminated
- 2022-09-29
- Firm location
- Exeter, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Simpleware ScanIP 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.