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U.S. Department of Health and Human Services

Class 2 Device Recall Philips PageWriter Touch

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 Class 2 Recall
Philips PageWriter Touch
see related information
Date Posted January 30, 2008
Recall Status1 Open
Recall Number Z-0124-2008
Recall Event ID 44824
Premarket Notification
510(K) Number
K020708 
Product Classification Electrocardiograph - Product Code DPS
Product Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810
Code Information Serial Numbers: US10603477 US60711180 US70711234 US80711276 US80711348 US80711386 US80711459 US10603478 US60711181 US70711235 US80711283 US80711349 US80711387 US80711460 US10603491 US60711182 US70711236 US80711284 US80711350 US80711388 US80711461 US10603493 US60711183 US70711241 US80711285 US80711351 US80711389 US80711462 US10603494 US60711184 US80503039 US80711286 US80711352 US80711390 US80711463 US10603495 US60711185 US80503049 US80711287 US80711353 US80711391 US90503082 US10603496 US60711186 US80711244 US80711288 US80711354 US80711392 US90503117 US10603497 US70711197 US80711245 US80711289 US80711355 US80711393 US90503119 US10603498 US70711199 US80711246 US80711290 US80711356 US80711394 US90503120 US10603499 US70711201 US80711247 US80711291 US80711357 US80711395 US90503121 US10603530 US70711205 US80711248 US80711292 US80711358 US80711396 US90503126 US10710463 US70711207 US80711249 US80711293 US80711359 US80711398 US90503127 US10710464 US70711208 US80711250 US80711294 US80711360 US80711399 US90503128 US10710465 US70711209 US80711251 US80711295 US80711361 US80711400 US90503129 US50502760 US70711210 US80711252 US80711296 US80711362 US80711402 US90503143 US50710968 US70711211 US80711253 US80711297 US80711363 US80711403 US90503148 US60502824 US70711212 US80711254 US80711298 US80711364 US80711404 US90503149 US60502825 US70711213 US80711255 US80711299 US80711365 US80711405 US90503150 US60502826 US70711214 US80711256 US80711300 US80711366 US80711406 US90503151 US60711064 US70711215 US80711257 US80711301 US80711367 US80711407 US90503152 US60711065 US70711216 US80711258 US80711302 US80711368 US80711408 US90503153 US60711067 US70711217 US80711259 US80711303 US80711369 US80711409 US90503154 US60711068 US70711218 US80711260 US80711304 US80711370 US80711411 US90503155 US60711070 US70711219 US80711261 US80711305 US80711371 US80711412 US90503156 US60711071 US70711220 US80711262 US80711306 US80711372 US80711413 US90503157 US60711073 US70711221 US80711263 US80711307 US80711373 US80711416 US90503158 US60711074 US70711222 US80711264 US80711308 US80711374 US80711417 US90503159 US60711075 US70711223 US80711265 US80711309 US80711375 US80711418 USD0301315 US60711076 US70711224 US80711266 US80711310 US80711376 US80711419 USD0610313 US60711077 US70711225 US80711267 US80711339 US80711377 US80711420 USN0301134 US60711078 US70711226 US80711268 US80711340 US80711378 US80711421 USN0400155 US60711079 US70711227 US80711269 US80711341 US80711379 US80711422 USN0402121 US60711080 US70711228 US80711270 US80711342 US80711380 US80711431 USN0402126 US60711081 US70711229 US80711271 US80711343 US80711381 US80711439 USN0402127 US60711176 US70711230 US80711272 US80711344 US80711382 US80711440 USN0402128 US60711177 US70711231 US80711273 US80711345 US80711383 US80711455 USN0402129 US60711178 US70711232 US80711274 US80711346 US80711384 US80711457 USN0610295 US60711179 US70711233 US80711275 US80711347 US80711385 US80711458 and USO0610104
Recalling Firm/
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, Massachusetts 01810
For Additional Information Contact Steve Smyth
978-687-1501
Manufacturer Reason
for Recall
Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Philips Medical Systems notified affected customers by Customer Letter and Urgent - Device Correction Notice dated 9/12/07. The correction will be a software upgrade. In the US, the Philips Response Center will contact US customers and arrange their upgrades, either via a software download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until new software is installed, customers are being advised to use the 12 lead module, and to disable or disconnect the 16 lead connection.
Quantity in Commerce 266 units
Distribution Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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