CLASS II Device recall · Reported 21 Jul 2021 · FDA Enforcement Report
PC Application recalled by C-rad Positioning Ab
C-rad Positioning AB is recalling PC Application, distributed nationwide in the US. The recall was initiated on 6 Aug 2020 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-2075-2021
- FDA event ID
- 88084
- Recalling firm
- C-rad Positioning AB, Uppsala
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2020
- FDA classified
- 14 Jul 2021
- Reported
- 21 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 6 Aug 2020 | Recall initiated by company | |
| 14 Jul 2021 | Classified by FDA | +342 days |
| 21 Jul 2021 | 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
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Where it was distributed
US Nationwide distribution in the states of IL, KY, MO and WA.
Questions about this recall
Why was it recalled?
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Which lots are affected?
Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
Where was it sold?
US Nationwide distribution in the states of IL, KY, MO and WA.
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.
More recalls from C-rad Positioning AB
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Catalyst, Catalyst+ recalled by C-rad Positioning Ab | C-rad Positioning AB | Device Malfunction | Nationwide |
| Device | CLASS II | Brand Name: Catalyst+ Product Name: C4D software used in conjunction recalled | C-rad Positioning AB | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |