CLASS II Device recall · Reported 17 Sep 2014 · FDA Enforcement Report
Radiance v. 2.4X, 2.5X and 2.6X recalled by Radiometer America
Radiometer America is recalling Radiance v. 2.4X, 2.5X and 2.6X, distributed nationwide in the US. The recall was initiated on 28 Jul 2014 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-2597-2014
- FDA event ID
- 68982
- Recalling firm
- Radiometer America, Westlake, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jul 2014
- FDA classified
- 5 Sep 2014
- Reported
- 17 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 28 Jul 2014 | Recall initiated by company | |
| 5 Sep 2014 | Classified by FDA | +39 days |
| 17 Sep 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Not stated in the enforcement report.
Product as listed by the FDA
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
Where it was distributed
Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.
Questions about this recall
Why was it recalled?
The reason has not been published.
Which lots are affected?
Verions 2.4X, 2.5X and 2.6X
Where was it sold?
Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.
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 Radiometer America
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ABL90 FLEX Analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | 36 states |
| Device | CLASS II | ABL800 FLEX with Crea recalled by Radiometer America | Radiometer America | Other | 31 states |
| Device | CLASS II | ABL800 analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | Nationwide |
| Device | CLASS II | ABL90 FLEX analyzers recalled by Radiometer America | Radiometer America | Device Malfunction | CA |
| Device | CLASS II | ABL800 analyzer with Flexq module recalled by Radiometer America | Radiometer America | Other | Nationwide |
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| Device | CLASS II | nGenuity Patient Monitor with Capnography recalled | Criticare Technologies | Device Malfunction | Nationwide |
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |