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Philips Medical Systems Nederlands recalls OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Recalled July 4, 2018 · FDA recall Z-2301-2018 · 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. · FDA Class II
Units
477
Sold at
US nationwide distribution.
Description
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.
Product
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Manufacturer(s)
Philips Medical Systems Nederlands
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →