Recalling Firm / Manufacturer

Siemens Medical Solutions.

Product

4Z1c matrix array transducer used in ACUSON SC 2000 ultrasound system

Description

SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medial data obtained by a physician for clinical diagnosis purposes.

4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system

Code Information

ACUSON SC 2000 ultrasound system Material Number: 10033682: Serial number of systems: 400212 400213 400215 400251 400405 400240 400089 400090 400104 400109 400149 400171 400289 400302 400334 400337 400183 400218 400209 400219 400259 400126 400247 400257 400260 400263 400281 400116 400165 400214 400420 400216 400253 400403 400412 400343 400185 400026 400044 400045 400084 400086 400088 400091 400102 400111 400114 400117 400118 400121 400124 400129 400132 400135 400139 400142 400143 400145 400146 400148 400156 400162 400168 400174 400176 400179 400202 400203 400206 400217 400220 400221 400222 400223 400224 400225 400227 400228 400229 400230 400232 400233 400234 400235 400236 400238 400239 400242 400243 400244 400258 400268 400269 400270 400272 400282 400287 400288 400290 400291 400293 400295 400297 400303 400304 400312 400314 400316 400336 400435 400449 400294 400127 400043 400125 400199 400200 400208 400113 400120 400237 400241 400332 400335 400413 400419 400158 400160 400161 400170 400172 400181 400182 400184 400187 400191 400201 400211 400249 400250 400299 400115 400155 400157 400207 400416 400424 400189 400195 400197 400166

4Z1c matrix array transducer Material number: 10433816: Serial numbers: 82638701 82741703 84254503 84355608 84455108 84754522 84857919 91861815 84858401 84655617 91654526 83044913 90261810 90864208 01288401 61101009 61601024 81631208 83146817 83251905 83751103 83752419 84455113 84557302 84753934 84857907 85056212 91503602 93771403 94982205 83650009 90656713 95183003 84456707 84153940 84857908 84857918 84953903 92068501 92256206 82540305 84053927 83853304 84656203 94065109

Reason of Recall

There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.

Date Recall Initiated

September 29, 2010

Action

The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a hot spot that exhibits a visible blister on the patient contact surface and feels hot to the touch during operation, and to pass this notice on to all those within their organization who need to be aware

Contact

Abdulrauf Ibrahim Batterjee & Bros. Company
Jeddah
(02) 6602933

Source

FDA

FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.