| Date Initiated by Firm |
February 22, 2021 |
| Create Date |
March 16, 2021 |
| Recall Status1 |
Terminated 3 on February 09, 2023 |
| Recall Number |
Z-1265-2021 |
| Recall Event ID |
87427 |
| 510(K)Number |
K180015
|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product |
Incisive CT Computed Tomography X-ray System
Model: 728143 |
| Code Information |
Serial Numbers: US: 500230 OUS: 500246 500260 500277 500261 530004 530102 530101 530103 530107 530109 530108 530113 530110 530119 530118 530117 530120 530125 530121 530124 530128 530126 530127 530129 530130 530132 530133 530134 530135 530136 530137 530139 530141 530138 530140 530144 530143 530145 530148 530146 530142 530147 530149 530154 530151 530158 530150 530153 530152 530157 530156 530159 530165 530161 530160 530162 530164 530163 530166 530171 530167 530168 530170 530169 530174 530173 530176 530185 530179 530172 530177 530196 530200 530201 530211 530212 530219 530221 500048 500231 500244 500247 500254 500257 500273 500270 500269 500226 500227 500241 500276 500229 500245 500248 500274 500263 500258 500278 500286 500225 500233 500256 500264 500265 UDI: (01)00884838059849(21)304034 (01)00884838059849(21)325078 (01)00884838085015(21)500218 (01)00884838085015(21)500219 (01)00884838085015(21)500221 (01)00884838085015(21)500222 (01)00884838085015(21)500223 (01)00884838085015(21)500224 (01)00884838085015(21)500225 (01)00884838085015(21)500226 (01)00884838085015(21)500227 (01)00884838085015(21)500229 (01)00884838085015(21)500231 (01)00884838085015(21)500233 (01)00884838085015(21)500234 (01)00884838085015(21)500237 (01)00884838085015(21)500238 (01)00884838085015(21)500239 (01)00884838085015(21)500241 (01)00884838085015(21)500242 (01)00884838085015(21)500245 (01)00884838085015(21)500247 (01)00884838085015(21)500248 (01)00884838085015(21)500249 (01)00884838085015(21)500251 (01)00884838085015(21)500252 (01)00884838085015(21)500254 (01)00884838085015(21)500255 (01)00884838085015(21)500256 (01)00884838085015(21)500257 (01)00884838085015(21)500258 (01)00884838085015(21)500261 (01)00884838085015(21)500264 (01)00884838085015(21)500274 (01)00884838085015(21)500283 (01)00884838085015(21)500296 (01)00884838085015(21)530038 (01)00884838085015(21)530107 (01)00884838085015(21)530108 (01)00884838085015(21)530109 (01)00884838085015(21)530113 (01)00884838085015(21)530117 (01)00884838085015(21)530118 (01)00884838085015(21)530119 (01)00884838085015(21)530120 (01)00884838085015(21)530121 (01)00884838085015(21)530124 (01)00884838085015(21)530125 (01)00884838085015(21)530126 (01)00884838085015(21)530127 (01)00884838085015(21)530128 (01)00884838085015(21)530129 (01)00884838085015(21)530130 (01)00884838085015(21)530132 (01)00884838085015(21)530133 (01)00884838085015(21)530134 (01)00884838085015(21)530135 (01)00884838085015(21)530136 (01)00884838085015(21)530137 (01)00884838085015(21)530138 (01)00884838085015(21)530139 (01)00884838085015(21)530140 (01)00884838085015(21)530141 (01)00884838085015(21)530142 (01)00884838085015(21)530143 (01)00884838085015(21)530144 (01)00884838085015(21)530145 (01)00884838085015(21)530146 (01)00884838085015(21)530147 (01)00884838085015(21)530148 (01)00884838085015(21)530149 (01)00884838085015(21)530150 (01)00884838085015(21)530151 (01)00884838085015(21)530152 (01)00884838085015(21)530153 (01)00884838085015(21)530154 (01)00884838085015(21)530156 (01)00884838085015(21)530157 (01)00884838085015(21)530158 (01)00884838085015(21)530159 (01)00884838085015(21)530160 (01)00884838085015(21)530161 (01)00884838085015(21)530162 (01)00884838085015(21)530163 (01)00884838085015(21)530164 (01)00884838085015(21)530165 (01)00884838085015(21)530166 (01)00884838085015(21)530167 (01)00884838085015(21)530168 (01)00884838085015(21)530169 (01)00884838085015(21)530170 (01)00884838085015(21)530171 (01)00884838085015(21)530172 (01)00884838085015(21)530173 (01)00884838085015(21)530174 (01)00884838085015(21)530176 (01)00884838085015(21)530177 (01)00884838085015(21)530179 (01)00884838085015(21)530180 (01)00884838085015(21)530185 (01)00884838085015(21)530196 (01)00884838085015(21)530200 (01)00884838085015(21)530211 (01)00884838085015(21)530219 (01)00884838085015(21)530221 |
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall |
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
|
FDA Determined
Cause 2 |
Process control |
| Action |
Philips notified US consignee on 2/22/2021via email including the Field Safety Notice informing of the reason for recall, health risk and action to take:
stop using the system until a Philips Field Service engineer arrives on site to implement the correction to lock the gantry tilt function (FCO72800745). After the FCO72800745 implementation, the device can continue to operate without
tilt function until the final correction (FCO72800742) is implemented to replace the nonconforming actuators which will remedy the issue and return device to normal use.
A Philips Service Engineer will contact you to schedule the Field Actions.
Both of the Field Actions FCO72800745 & FCO72800742 will be free of charge. |
| Quantity in Commerce |
105 units (1 US and 104 OUS) |
| Distribution |
US Virgin Island
Foreign:
Australia
Bolivia
China
Germany
Hungary
Indonesia
Italy
Japan
Korea
Korea, Republic of
Latvia
Palestine
Philippines
Romania
Russian Federation
Senegal
Thailand
Uzbekistan |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = Philips Healthcare (Suzhou) Co., Ltd.
|
