FDA-Device2018-07-04Class II
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Philips Medical Systems Nederlands
Hazard
The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.
Sold states
US nationwide distribution.
Affected count
477
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2018Don't want to check this manually?
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