Z-1604-2018Class II

708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy...

Name: Z-1604-2018 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy...
Creator: Philips Medical Systems Nederlands
Published: 2018-03-26
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2018-03-26 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems Nederlands began a recall of 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with... on 2018-03-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1604-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Posted: 2018-05-03
Terminated: 2020-06-12
Recalling firm: Philips Medical Systems Nederland B.V.
Product: 708033 URODiagnost 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.
Product code: IXR Table, Radiographic, Tilting
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, BU IGT Systems, sent an "URGENT- Field Safety Notice" letter dated 3/23/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the system and call your Philips representative if the following situations occurs: -the table height or tilt movement is not working. - you notice a cracking or snapping sound during system operation. - you experience a blockade in the table height or tilt movement during system movements. -the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. - you have used a CPR stand that obstructed the system, or - you notice any (other) unusual system behavior beyond the normal use of the system. The customers should also avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. In addition, ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. The firm stated: -All possibly affected products in the field will be corrected by means of a field change order free of charge. -A firm representative will replace affected material on the upper and lower tilt actuator in the affected systems. -You will be contacted by our local Philips representative to schedule this corrective action. -This action will start effective April 2018. 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: 20
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.
Product codes and lots: System Serial # 8 14 1 64 15 4 3 7 18 48 16 2 59 60 17 11 13 21 5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1604-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1603-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1604-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1605-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1606-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1607-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1608-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03
Z-1609-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03

Product code IXR

K911098Class IIPhilips Uro Diagnost MrfPhilips Medical Systems, Inc. / cleared 1991-07-03

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)