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Proteus XR/a recallZ-1752-2019 · GE Healthcare, LLC · initiated Mar 29, 2019

Class II Terminated All recalls posted in June 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1752-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 29, 2019
Posted by the FDA
Jun 10, 2019
Recalling firm
GE Healthcare, LLC
Quantity
825 (38 US and 787 OUS) in total
Product code
KPR
FDA submissions
K993090
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 description

Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.

Code information (models, lots, serial numbers)

651789WDR1 and PL1005RX03

Other devices under the same FDA submission

1 device cleared under K993090 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page