Z-1607-2018Class II

Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging...

Name: Z-1607-2018 Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging...
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 Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy... 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-1607-2018
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: Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 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: 199
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 # 40 239 123 58 88 172 129 81 136 159 244 238 82 65 249 70 142 188 128 178 117 45 203 79 229 199 126 158 71 60 187 47 197 87 152 105 76 26 124 139 35 15 66 241 150 86 230 22 206 207 222 146 29 151 111 190 59 228 155 4 233 92 30 221 163 201 91 69 44 205 48 18 34 171 110 175 121 174 43 160 185 23 202 209 95 144 50 141 156 708032/14 72 93 98 193 262 189 118 218 153 33 104 53 216 177 116 38 64 196 49 181 37 180 164 240 135 183 17 125 170 54 NL73 113 90 24 6 27 42 73 246 133 84 214 83 192 149 169 62 61 191 195 100 227 236 97 99 101 102 46 219 103 226 173 89 140 2 36 20 80 32 161 5 51 94 12 176 212 179 25 96 39 154 63 182 157 85 200 234 19 132 21 165 13 120 41 10 56 55 3 7 8 106 114 108 213 14 115 107 31 112

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1607-2018
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)