Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and f
Summary
The FDA issued a Class II for Simpleware ScanIP medical software. For transfer of imaging information from a by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE. Reason: A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed inco.
Details
Source
Device Recall
External ID
Z-2254-2021
Action Date
2021-08-18
Status
Terminated
Category
device
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.
Lot/Code Info: Affected version/UDI: Simpleware ScanIP Medical; Simpleware ScanIP O-2018.12: 00863520000338, Simpleware ScanIP Medical; Simpleware ScanIP P-2019.09: 00863520000345, Simpleware ScanIP Medical; Simpleware ScanIP Q-2020.03: 00863520000369, Simpleware ScanIP Medical; Simpleware ScanIP Q-2020.06: 00863520000352, Simpleware ScanIP Medical; Simpleware ScanIP R-2020.09: 00863520000376, Simpleware ScanIP Medical; Simpleware ScanIP R-2021.03: 00863520000383
Quantity Affected: 6 software's
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
Distribution
US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-04
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Simpleware Product Group, SYNOPSYS NORTHERN EUROPE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Simpleware Product Group, SYNOPSYS NORTHERN EUROPE have FDA actions?
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2254-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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