OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Reported: July 4, 2018 Initiated: May 1, 2018 #Z-2300-2018
Product Description
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Reason for Recall
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.
Details
- Recalling Firm
- Philips Medical Systems Nederlands
- Units Affected
- 508
- Distribution
- US nationwide distribution.
- Location
- Best
Frequently Asked Questions
What product was recalled? ▼
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028. Recalled by Philips Medical Systems Nederlands. Units affected: 508.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2300-2018.
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