CLASS II Device recall · Reported 6 Feb 2013 · FDA Enforcement Report
Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products recalled
Motorola is recalling Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products, distributed nationwide in the US. The recall was initiated on 27 Apr 2012 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-0516-2013
- FDA event ID
- 61870
- Recalling firm
- Motorola, Holtsville, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2012
- FDA classified
- 30 Jan 2013
- Reported
- 6 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Apr 2012 | Recall initiated by company | |
| 30 Jan 2013 | Classified by FDA | +278 days |
| 6 Feb 2013 | 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
It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.
Product as listed by the FDA
Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
Where it was distributed
Nationwide distribution
Questions about this recall
Is Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products recalled?
Yes. Motorola recalled Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products on 27 Apr 2012. The recall is Class II and its status is Terminated. Recall number Z-0516-2013.
Why was it recalled?
It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.
Which lots are affected?
Motorola Solutions PCS3000/CS3070 Laser
Where was it sold?
Nationwide distribution
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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