Home / Recalls / Philips Electronics North America Corporation / Z-1439-2018

Z-1439-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
April 25, 2018
Initiation Date
March 16, 2018
Termination Date
April 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,205 units in total

Product Description

ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

Reason for Recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Distribution Pattern

Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Republic of Korea - South Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lesotho, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mauritius, Mexico, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen & Zimbabwe.

Code Information

(Added 6/25/18): 5097 5426 5519 5507 5255 5059 5379 5257 5316 5144 5002 5300 5440 5482 5014 5492 5019 5423 5256 5293 5382 5319 5420 5030 5477 5488 5193 5085 5347 5287 5195 5481 5370 5474 5360 5352 5106 5135 5495 5313 5413 5245 5142 5378 5411 5214 5151 5053 5222 5201 5381 5246 5306 5429 5441 5324 5273 5048 5124 5211 5453 5277 5533 5239 5248 5349 5414 5311 5513 5204 5215 5434 5577 5296 5259 5271 5512 5373 5542 5290 5091 5446 5266 5406 5551 5090 5455 5123 5261 5323 5390 5254 5353 5502 5241 5514 5238 5035 5105 5333 5454 5226 5334 5328 5417 5298 5451 5288 5200 5077 5250 5342 5309 5172 5432 5081 5199 5458 5573 5568 5268 5110 5472 5052 5009 5461 5022 5297 5263 5158 5078 5230 5558 5428 5303 5376 5515 5520 5269 5394 5253 5282 5042 5155 5084 5047 5530 5501 5383 5497 5016 5329 5162 5143 5491 5470 5566 5071 5079 5258 5125 5283 5129 5475 5574 5149 5018 5421 5473 5227 5330 5264 5132 5141 5327 5265 5351 5121 5216 5236 5180 5487 5478 5116 5160 5345 5301 5522 5083 5391 5021 5552 5314 5363 5024

Other recalls by Philips Electronics North America Corporation

  • Z-0614-2019 Class II — Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6. (November 15, 2018)
  • Z-0592-2019 Class II — IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Pro (October 10, 2018)
  • Z-3235-2018 Class II — Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and (July 16, 2018)
  • Z-3228-2018 Class II — AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3232-2018 Class II — Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and n (July 16, 2018)
  • Z-3237-2018 Class II — Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and ne (July 16, 2018)
  • Z-3213-2018 Class II — INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3236-2018 Class II — Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascul (July 16, 2018)
  • Z-3238-2018 Class II — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular a (July 16, 2018)
  • Z-3239-2018 Class II — Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and (July 16, 2018)