Class 2 Device Recall TriaDyne Proventa Critical Care Therapy System

• Date Initiated by Firm: December 03, 2014
• Date Posted: February 27, 2015
• Recall Status: Terminated on October 30, 2015
• Recall Number: Z-1218-2015
• Recall Event ID: 69970
• Product Classification: Bed, patient rotation, powered - Product Code IKZ
• Product: TriaDyne Proventa Critical Care Therapy System.; ; The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
• Code Information: SERIAL NUMBERS: TDBK00046 TDBK00096 TDDK00006 TDDK00008 TDDK00122 TDDK00126 TDDK00254 TDBK00281 TDDK00265 TDBK00292 TDBK00134 TDDK00036 TDDK00149 TDDK00363 TDBK00323 TDBK00355 TDBK00370 TDDK00035 TDDK00066 TDBK00348 TDBK00360 TDDK00184 TDDK00242 TDGK00116 TDGK00117 TDGK00123 TDBK00049 TDGK00024 TDDK00118 TDBK00349 TDDK00021 TDDK00245 TDBK00033 TDBK00250 TDBK00320 TDDK00054 TDDK00158 TDDK00224 TDGK00026 TDGK00032 TDBK00070 TDDK00062 TDDK00231 TDDK00278 TDBK00131 TDBK00284 TDBK00319 TDBK00367 TDDK00121 TDDK00255 TDDK00285 TDBK00058 TDBK00280 TDDK00202 TDDK00217 TDDK00005 TDDK00155 TDDK00183 TDDK00252 TDDK00269 TDBK00099 TDBK00339 TDDK00268 TDDK00330 TDBK00306 TDBK00253 TDBK00271 TDDK00082 TDDK00084 TDDK00362 TDGK00004 TDGK00031 TDGK00130 TDGK00147 TDBK00379 TDDK00142 TDDK00146 TDDK00334 TDGK00019 TDGK00108 TDGK00168 TDGK00169 TDLK00010 TDLK00011 TDLK00015 TDDK00052 TDBK00301 TDBK00359 TDDK00009 TDDK00093 TDDK00322 TDGK00003 TDGK00007 TDDK00071 TDBK00148 TDBK00153 TDBK00272 TDBK00392 TDDK00161 TDGK00012 TDDK00365 TDBK00393 TDDK00116 TDDK00181 TDBK00361 TDDK00124 TDBK00012 TDDK00220 TDBK00097 TDGK00008 TDGK00139 TDGK00144 TDDK00018 TDDK00055 TDGK00155 TDDK00359 TDGK00115 TDDK00212 TDBK00342 TDDK00264 TDGK00118 TDBK00041 TDDK00120 TDBK00326 TDDK00298 TDDK00194 TDBK00053 TDDK00135 TDGK00153 TDLK00014 TDDK00191 TDBK00304 TDDK00260 TDDK00127 TDDK00325 TDBK00150 TDBK00324 TDBK00340 TDBK00303 TDDK00226 TDBK00158 TDGK00129 TDGK00140 TDDK00117 TDDK00134 TDGK00121 TDDK00333 TDBK00334 TDDK00064 TDDK00102 TDBK00265 TDBK00373 TDDK00172 TDBK00286 TDDK00089 TDDK00277 TDDK00296 TDGK00027 TDGK00088 TDBK00343 TDDK00106 TDDK00213 TDDK00034 TDBK00043 TDGK00069 TDGK00089 TDGK00095 TDBK00368 TDGK00043 TDGK00085 TDGK00093 TDDK00211 TDDK00289 TDDK00063 TDDK00248 TDDK00356 TDBK00346 TDBK00352 TDDK00020 TDDK00092 TDDK00109 TDDK00130 TDDK00186 TDDK00270 TDDK00283 TDDK00275 TDBK00252 TDBK00276 TDDK00187 TDDK00199 TDDK00261 TDGK00113 TDBK00390 TDDK00119 TDBK00305 TDDK00026 TDDK00028 TDDK00051 TDDK00195 TDDK00336 TDBK00347 TDDK00069 TDDK00230 TDGK00029 TDGK00102 TDGK00110 TDBK00142 TDBK00366 TDDK00138 TDDK00332 TDDK00053 TDGK00097 TDGK00104 TDGK00107 TDGK00114 TDBK00277 TDLK00003 TDLK00012 TDLK00016 TDDK00346 TDGK00076 TDGK00098 TDBK00052 TDBK00138 TDBK00350 TDBK00351 TDDK00200 TDDK00287 TDDK00339 TDBK00161 TDDK00070 TDBK00108 TDDK00040 TDDK00056 TDDK00150 TDDK00153 TDDK00335 TDDK00357 TDDK00294 TDGK00025 TDBK00156 TDBK00255 TDGK00096 TDGK00127 TDGK00132 TDGK00133 TDGK00135 TDGK00141 TDGK00154 TDGK00056 TDGK00080 TDGK00082 TDGK00109 TDGK00112 TDBK00157 TDBK00251 TDBK00269 TDDK00144 TDDK00151 TDDK00358 TDDK00360 TDDK00263 TDDK00345 TDDK00019 TDBK00159 TDBK00297 TDBK00045 TDGK00106 TDLK00013 TDBK00135 TDDK00033 TDDK00140 TDBK00273 TDBK00356 TDDK00300 TDDK00207 TDDK00198 TDBK00310 TDBK00333 TDDK00059 TDDK00353 TDBK00335 TDDK00274 TDDK00337 TDDK00348 TDDK00027 TDDK00189 TDGK00167 TDBK00354 TDBK00085 TDBK00278 TDDK00060 TDBK00295 TDBK00311 TDDK00025 TDDK00233 TDDK00137 TDDK00253 TDDK00286 TDDK00303 TDBK00282 TDDK00276 TDBK00068 TDDK00185 TDDK00340 TDBK00106 TDGK00166 TDDK00327 TDDK00145 TDDK00234 TDLK00017 TDGK00074 TDBK00166 TDBK00369 TDDK00103 TDDK00354 TDDK00279 TDDK00045 TDGK00105 TDBK00030 TDBK00331 TDGK00068 TDBK00337 TDDK00209 TDBK00036 TDDK00197 TDBK00353 TDDK00065 TDGK00100 TDDK00031 TDGK00170 TDDK00132 TDGK00094 TDDK00068 TDDK00243 TDDK00344 TDDK00258 TDBK00365 TDGK00142 TDGK00148 TDGK00091 TDBK00067 TDDK00208 TDDK00351 TDDK00182 TDGK00047 TDGK00111 TDLK00009 TDDK00032 TDDK00352 TDDK00154 TDBK00256 TDGK00083 TDBK00050 TDBK00062 TDBK00332 TDDK00098 TDGK00033 TDBK00372 TDDK00041 TDDK00204 TDBK00262 TDDK00047 TDDK00075 TDDK00170 TDBK00060 TDGK00010 TDGK00011 TDBK00071 TDBK00263 TDBK00300 TDBK00358 TDBK00375 TDDK00039 TDDK00043 TDDK00044 TDDK00081 TDDK00113 TDDK00168 TDDK00179 TDDK00188 TDDK00341 TDDK00361 TDGK00013 TDGK00021 TDGK00036 TDGK00059 TDGK00157 TDGK00158 TDGK00159 TDGK00163 TDDK00301 TDDK00307 TDGK00001 TDGK00006 TDGK00023 TDGK00120 TDGK00124 TDGK00138 TDGK00146 TDDK00297 TDDK00096 TDBK00064 TDBK00257 TDBK00299 TDDK00125 TDDK00290 TDGK00030 TDGK00060 TDGK00090 TDGK00125 TDBK00094 TDBK00249 TDBK00377 TDDK00015 TDDK00049 TDDK00156 TDDK00176 TDDK00177 TDGK00005 TDGK00016 TDBK00061 TDDK00305 TDGK00014 TDGK00162 TDGK00122 TDGK00145 TDBK00258 TDDK00171 TDGK00058 TDGK00022 TDBK00275 TDDK00293 TDBK00028 TDGK00035 TDGK00063 TDGK00152 TDBK00165 TDBK00266 TDDK00299 TDDK00087 TDDK00104 TDDK00237 TDDK00173 TDGK00038 TDGK00018 TDGK00064 TDGK00061 TDGK00128 TDGK00039 TDDK00291 TDGK00164 TDGK00160 TDGK00020 TDGK00143 TDDK00050 TDDK00295 TDLK00005 TDDK00114 TDBK00328 TDGK00066 TDGK00073 TDGK00084 TDGK00101 TDGK00103 TDBK00279 TDGK00028 TDBK00336 TDDK00350 TDBK00293 TDBK00312 TDGK00077 TDGK00173 TDGK00176 TDGK00072 TDBK00149 TDDK00131 TDGK00042 TDDK00201 TDGK00078 TDGK00079 TDDK00259 TDBK00163 TDLK00018 TDDK00048 TDDK00302 TDBK00151 TDDK00328 TDGK00071 TDGK00081 TDGK00087 TDGK00099 TDGK00175 TDGK00177 TDBK00307 TDBK00329 TDBK00374 TDDK00086 TDDK00206 TDDK00244 TDDK00331 TDDK00349 TDGK00055 TDDK00343 TDBK00152 TDBK00143 TDDK00262 TDDK00288 TDDK00338 TDGK00131 TDGK00075 TDBK00140 TDDK00133 TDGK00171 TDBK00260 TDBK00287 TDDK00180 TDDK00143 TDGK00009 TDGK00086 TDBK00362 TDDK00239 TDBK00330 TDBK00057 TDBK00021 TDBK00378 TDDK00216 TDDK00136 TDBK00376 TDDK00342 TDBK00038 TDDK00329 TDBK00308 TDBK00289 TDBK00039 TDDK00160 TDGK00015 TDGK00034 TDGK00065 TDGK00156 TDBK00154 TDGK00165 TDGK00044 TDBK00126 TDGK00067 TDGK00151 TDDK00105 TDGK00161 TDGK00149 TDBK00298 TDDK00178 TDDK00251
• Recalling Firm/ Manufacturer: Arjo Hospital Equipment AB; HANS MICHELSENSGATAN 10; Malm¿ Sweden
• Manufacturer Reason for Recall: The recalled devices labeling and instructions for use contain unapproved medical claims.
• FDA Determined Cause: Labeling design
• Action: Devices in the rental fleet will be delivered to the customer with revised documents including the updated information. The customers who purchased the devices will be notified of the recall via letter sent by registered mail. The field correction notice will include a recall letter, response form, and updated labeling.
• Quantity in Commerce: 567 units
• Distribution: Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
• 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.