Z-3237-2018Class II

Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications...

Name: Z-3237-2018 Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications...
Creator: Philips Electronics North America Corporation
Published: 2018-07-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-07-16 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including... on 2018-07-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3237-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-16
Posted: 2018-09-21
Terminated: 2022-11-18
Recalling firm: Philips North America LLC
Product: Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Product code: IZF System, X-Ray, Tomographic
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, BU IGT System, sent an "Urgent -Medical Device Correction" notification letter dated 07/16/2018 to customers. The letter describes the product, problem and actions to be taken. The letter instructs customers to do the following: In order to reduce the risk for patients, users and bystanders if this problem would reoccur, we recommend the following actions until the correction has been implemented. -Avoid unnecessary movements of the Monitor Ceiling Suspension. -For those movements that are necessary, avoid that the user, patient or bystander are in close proximity to the monitor. -When moving the Monitor Ceiling Suspension, ensure that no body partsof the staff or patient are underneath the monitor. -Do not move the monitor above the patient. Please ensure that all staff with access to the affected systems are informed of the content of this Medical Device Correction. All affected products will be corrected by means of a Field Change Order (FCO) free of charge. This FCO will be available mid-August. You will be contacted by our local Philips representative to schedule this corrective action. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722- 9377, 8am to 8pm (EST) Monday thru Friday.
Quantity in commerce: 5115 total
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 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.
Product codes and lots: All systems with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 2011 are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3237-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3213-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3214-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3215-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3216-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3217-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3218-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3219-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3220-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3221-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3222-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3223-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3224-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3225-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3226-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3227-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3228-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3229-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3230-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3231-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3232-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3233-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3234-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3235-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3236-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3237-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3238-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21
Z-3239-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-21

Product code IZF

K925302Class IIPhilips Integris H/hm SystemPhilips Medical Systems, Inc. / cleared 1992-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)