Z-1755-2019Class II

Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum...

Name: Z-1755-2019 Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum...
Creator: GE Healthcare, LLC
Published: 2019-03-29
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-03-29 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design on 2019-03-29. FDA classified it as Class II and gives the reason as "There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1755-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-29
Posted: 2019-06-10
Terminated: 2021-04-15
Recalling firm: GE Healthcare
Product: Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Product code: KPR System, X-Ray, Stationary
Reason for recall: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Root cause tag: design
FDA root cause: Device Design
Action: On March 29, 2019, GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated March 29, 2019 to its consignees/customers. The letter described the product, problem and actions to be taken. Customers were instructed to do the following: Please follow the precautions below until the monitor feet on your unit are replaced: -The CRT monitor and suspension should be inspected and used with caution. Make sure the monitors are secured properly to the tray before each use. -Immediately stop using the system if any looseness of the monitor is noticed and contact your GE service representative. -Monitor should not be positioned directly above the patient. -Before service or preventative maintenance of the monitor is attempted, review the service and preventive maintenance procedures. Also the customer were instructed to complete and return the MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED form by scanning or taking a photo of the completed form e-mailing to: [email protected]. F/U visits by GE Healthcare will be made to replace the plastic feet. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 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.
Product codes and lots: DZ1061RX02 and UP389014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1755-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1751-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-10
Z-1752-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-10
Z-1753-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-10
Z-1754-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-10
Z-1755-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-10

Product code KPR

K982955Class IISilhouette VrGE Medical Systems / cleared 1998-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)