Recall Z-2300-2018— Philips Medical Systems Nederlands
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2018-05-01, terminated 2020-06-08. It names one FDA 510(k) clearance: K032046. Product: OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028. Reason: 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..
- Recalling firm
- Philips Medical Systems Nederlands
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-01
- Terminated
- 2020-06-08
- Firm location
- Best, Netherlands
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.