# FDA recall Z-3218-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2018-07-16.

## Product

INTEGRIS SUITE, System Code 722199     Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

## Reason for recall

There is a potential for the Monitor Ceiling Suspension, which holds  a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground.  When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of  injury for the patient, user and bystander.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of:  Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, British Virgin Islands, Brazil, Brunei Darussalam, Blugaria, Cambodia, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominic Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea South, Republic of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Reunion, Russia, Saudi Arab

## Key facts

- **Recall number:** Z-3218-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-16
- **Report date:** 2018-10-03
- **Termination date:** 2022-11-18

- **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-3218-2018

## Citation

> AI Analytics. FDA recall Z-3218-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3218-2018. Source: US FDA. Licensed CC0.

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