CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report

Integris Allura 9 (biplane), System recalled

Philips Electronics North America is recalling Integris Allura 9 (biplane), System, distributed nationwide in the US. The recall was initiated on 16 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll systems with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 2011 are affected

Quantity recalled5115 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3214-2018
FDA event ID: 80922
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2018
FDA classified: 21 Sep 2018
Reported: 3 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

16 Jul 2018	Recall initiated by company
21 Sep 2018	Classified by FDA	+67 days
3 Oct 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

Where it was distributed

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 Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, UAE, UK, Uzbekistan, Venezuela, Vietnam, and Yemen.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

All systems with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 2011 are affected

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

26 other products · FDA event 80922

This product is part of a recall event; the main page for the event is AIIuraXperFDlO/10, System recalled by Philips Electronics North.

Reported	Class	Recall	Company	Reason	Where
3 Oct 2018	CLASS II	AIIuraXperFDlO/10, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Integris CV, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper FD1O C, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Poly C- Dmcp-Visub(H3000), System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Integris Suite, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	AIIura Xper F010 DR Table, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper FD2O, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper FD2O, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Integris Allura 15-12 (mono), System recalled	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Ntegris Allura 9 0 Fdxd, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper F010/10 DRTable, System recalled	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper FD2O Biplane, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	AlIura Xper F010 F, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Integris Allura 9, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper F020 DR Table, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper F010 DR Table, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Cesar Powerpack-Visub(V3000), System recalled	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper F020 DR Table, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper F020 Biplane DR Table, System recalled	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Cesar-Dmcp-Visub(HM2000/3000), System recalled	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	AlluraXperFOlO/lO, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Integris Allura 15-12 (biplane), System recalled	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Integris Allura 9 F Fdxd, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	AIIuraXperFDlO, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper FD2O Biplane, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018	CLASS II	Allura Xper F010, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide

More recalls from Philips Electronics North America

All 160

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018Device	CLASS II	IntelliVue MX40 Patient Monitor recalled by Philips Electronics North	Philips Electronics North America	Device Malfunction	Nationwide
24 Oct 2018Device	CLASS II	Philips HeartStart FR3 Defibrillator recalled	Philips Electronics North America	Device Malfunction	Nationwide
3 Oct 2018Device	CLASS II	Allura Xper F010, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	Allura Xper FD2O Biplane, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide
3 Oct 2018Device	CLASS II	AIIuraXperFDlO, System recalled by Philips Electronics North	Philips Electronics North America	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide