Low FDA (Devices)·Z-2039-2016·Announced 2016-06-29

Leica Biosystems Recalls CytoVision Systems Due to Windows 7 Activation Issues

Leica Biosystems Richmond Inc. is recalling 283 CytoVision Image Analysis and Capture Systems because the Windows 7 operating system is improperly activated, appearing unlicensed.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software licensing/activation defect rather than a direct physical or biological hazard.

Plain-English summary

Leica Biosystems Richmond Inc. is recalling 283 CytoVision Image Analysis and Capture Systems. These automated cell-locating devices are used to assist operators in viewing chromosomes and looking for cellular anomalies. The recall affects systems distributed worldwide, including in the United States and numerous international locations.

The recall is due to an improperly activated Windows 7 operating system. Although a valid Windows 7 license was associated with each manufactured system, the systems appear to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures, requiring checks of each potentially affected system to confirm the operating system is properly activated.

The source text does not specify specific actions for consumers or healthcare providers beyond the need to check the systems. No illnesses, injuries, or deaths have been reported in association with this recall.

The recalled product

Product: CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoV
Manufacturer: Leica Biosystems Richmond Inc.
Category: Medical Device — Laboratory Equipment
Hazard: software-defect
Affected units: 283

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

System 23CAP001KXX001 with Serial Number 201021
System 23CAP001KXX001 with Serial Number 201020
System 23CAP001KXX001 with Serial Number 200994
System 23CAP001KFX001 with Serial Number 200752
System 23GSLXXXKFXUPG with Serial Number 201013
System 23GSLXXXKFXUPG with Serial Number 201050
System 23CAP007FXX001 with Serial Number 200930
System 23CAP002KFX001 with Serial Number 201000
System 23CAP001KXX001 with Serial Number 200969
System 23CAP001KFX001 with Serial Number 200942
System 23GSL120KFX001 with Serial Number 200910
System 23CAP001FXX001 with Serial Number 200710
System 23GSLXXXKFXUPG with Serial Number 200890
System 23GSLXXXKFXUPG with Serial Number 201087
System 23CUP003CVX720 with Serial Number 201086
System 23GSL10XKXX001 with Serial Number 201085
System 23REV001XXX001 with Serial Number 201084
System 23REV001XXX001 with Serial Number 201083
System 23REV001XXX001 with Serial Number 201082
System 23REV001XXX001 with Serial Number 201081

Distribution

Distributed nationwide across the United States.

Same manufacturer · Leica Biosystems Richmond Inc.

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Same hazard · software defect