Z-1603-2018Class II

MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy...

Name: Z-1603-2018 MultiDim Eleva 708032 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 MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along... 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-1603-2018
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: MultiDim Eleva 708032 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: KPR System, X-Ray, Stationary
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: 184
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 # 32 177 259 239 264 258 52 67 111 257 94 142 121 191 143 260 265 74 207 101 182 174 124 263 4 172 254 151 246 64 183 76 152 188 261 242 102 34 147 241 134 178 245 176 175 38 162 107 220 65 194 69 247 13 215 78 112 29 139 98 79 158 61 33 106 35 50 16 80 205 161 11 204 37 12 189 9 232 15 228 155 47 171 213 209 218 96 90 212 217 181 163 140 114 115 108 71 141 14 36 48 224 25 105 57 216 138 24 28 211 160 192 43 44 157 154 41 219 8 68 129 75 221 7 10 63 146 45 26 125 193 210 1 60 3 132 81 22 23 208 5 131 135 88 226 6 156 49 91 92 93 201 250 251 72 95 148 39 31 2 30 51 100 255 252 256 109 196 164 170 227 173 83 159 53 137 54 116 118 119 167 168 169 97

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1603-2018
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 KPR

K050151Class IIMultidiagnost ElevaPhilips Medical Systems North America, Inc. / cleared 2005-02-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)