OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

FDA device recall Z-2300-2018 · posted 2018-06-27 · Terminated

Recall details

Recalling firm

Philips Medical Systems Nederlands

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.

Action taken

On May 17, 2018, the firm issued Urgent Medical Device Correction letters to affected consignees. Customers were advised of the product issue. Customers were instructed to do the following: Stop using the system and call your Philips representative if any of the following situations occurs: . the table height or tilt movement is not working. . you notice a cracking sound or snapping sound different than the normal sound during height or tilt movement. . you experience a blockade in the table height or tilt movement during system movements. . the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. . you have used a CPR stand that obstructed the system, or . you notice any (other) unusual system behavior beyond the normal use of the system. Avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. Customer shall ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. The firm plans to correct all potentially affected products in the field by means of a field change order free of charge. Customers will be contacted by a local Philips representative to schedule the corrective action, which will start effective July 2018. Customer with further questions may contact Philips Technical Support Line: 1-800-722-9377.

Root cause

Device Design

Status

Terminated

Product code

JAA

Quantity affected

508

Distribution

US nationwide distribution.

Date initiated

2018-05-01

Date posted

2018-06-27

Date terminated

2020-06-08

Location

Best, Netherlands

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