# FDA recall Z-0717-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2017-12-20.

## Product

Allura Xper FD and and Xper FD ORT - Philips X-ray Systems    Product Usage:  The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for:   Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for:   Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis.   Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology.   Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally:   The Allur

## Reason for recall

Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of  the support arm can come loose because of vibrations and forces exerted on them.  If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can  topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.

## Distribution

Worldwide Distribution - US Nationwide

## Key facts

- **Recall number:** Z-0717-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-03-07
- **Termination date:** 2020-06-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2018

## Citation

> AI Analytics. FDA recall Z-0717-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0717-2018. Source: US FDA. Licensed CC0.

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