# FDA recall Z-1606-2018

> **Philips Medical Systems Nederlands** · Class II · device recall initiated 2018-03-26.

## Product

Mutlidiagnost-Eleva with Flat Detector 708034    As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

## Reason for recall

The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.

## Distribution

Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-1606-2018
- **Recalling firm:** Philips Medical Systems Nederlands
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-26
- **Report date:** 2018-05-09
- **Termination date:** 2020-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Best, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1606-2018

## Citation

> AI Analytics. FDA recall Z-1606-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1606-2018. Source: US FDA. Licensed CC0.

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