Class 2 Device Recall Philips

• Date Initiated by Firm: July 29, 2011
• Date Posted: September 30, 2011
• Recall Status: Terminated on May 23, 2012
• Recall Number: Z-3287-2011
• Recall Event ID: 59312
• 510(K)Number: K091459 K080652 K092217
• Product Classification: Spirometer, monitoring (w/wo alarm) - Product Code BZK
• Product: PHILIPS NM3 Monitor Model Number: 7900; PHILIPS NM3 Monitor, English; Part Number: 1051674; PHILIPS NM3 Monitor, English, Refurbished; Part Number : U1051674; PHILIPS NM3 Monitor, English, Demo Unit; Part Number: DU1051674; PHILIPS NM3 Monitor, Spanish; Part Number: 1060462; PHILIPS NM3 Monitor, French Part Number: 1060458; PHILIPS NM3 Monitor, Swedish Part Number:1062860; ; Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.
• Code Information: Serial Numbers Domestic: 00401 00189 00209 00049 00191 00194 00211 00339 00362 00290 00291 00294 00295 00297 00300 00301 00302 00309 00311 00119 00360 00306 00451 00455 00212 00357 00351 00075 00111 00115 00126 00129 00132 00096 00120 00121 00123 00125 00127 00128 00131 00057 00110 00133 00150 00173 00214 00326 00058 00066 00063 00070 00145 00041 00055 00148 00245 00082 00184 00188 00203 00204 00254 00399 00400 00167 00207 00241 00242 00248 00249 00250 00251 00130 00377 00353 00352 00358 00354 00355 00359 00042 00124 00272 00113 00210 00240 00164 00218 00303 00304 00308 00160 00172 00217 00364 00087 00089 00298 00314 00322 00078 00313 00315 00084 00092 00219 00252 00266 00279 00285 00286 00246 00244 00243 00340 00345 00346 00349 00365 00372 00375 00380 00382 00383 00384 00385 00387 00388 00392 00366 00208 00104 00391 00097 00102 00361 00363 00367 00368 00225 00374 00404 00411 00370 00373 00193 00222 00423 00427 00114 00118 00067 00398 00183 00186 00262 00293 00331 00333 00335 00336 00261 00299 00356 00267 00046 00122 00154 00109 00190 00247 00394 00381 00378 00369 00074 00080 00081 00098 00103 00105 00107 00116 00187 00071 00072 00073 00076 00083 00088 00093 00100 00101 00117 00112 00344 00376 00277 00289 00079 00099 00106 00108 00317 00319 00321 00085 00318 00320 00135 00200 00265 00280 00144 00179 00181 00182 00205 00077 00086 00090 00091 00094 00195 00198 00253 00255 00256 00260 Foreign: 00379 00422 00425 00476 00389 00428 00305 00310 00350 00409 00421 00269 00273 00274 00275 00287 00288 00263 00237 00332 00323 00316 00390, and 00393.
• Recalling Firm/ Manufacturer: Respironics Novametrix, LLC.; 5 Technology Dr; Wallingford CT 06492-1942
• For Additional Information Contact: Todd M. Coutire; 203-697-6348
• Manufacturer Reason for Recall: Pressure lines maybe occluded and display incorrect tidal volumes.
• FDA Determined Cause: Manufacturing material removal
• Action: Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.
• Quantity in Commerce: 254 units
• Distribution: Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
• 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 = BZK and Original Applicant = RESPIRONICS NOVAMETRIX LLC; 510(K)s with Product Code = BZK and Original Applicant = RESPIRONICS NOVAMETRIX, INC.