FDAClass IIJune 19, 2019

Silhouette VR This fully integrated system offers recall

Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.

Why was Silhouette VR This fully integrated system offers recalled?

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

DZ1061RX02 and UP389014.

Product
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Recalling firm
GE Healthcare, LLC
Quantity
825 (38 US and 787 OUS) in total
Distribution
Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.
Recall date
June 19, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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