ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce c...
FDA Device Recall #Z-1439-2018 — Class II — March 16, 2018
Recall Summary
| Recall Number | Z-1439-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 16, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Electronics North America Corporation |
| Location | Andover, MA |
| Product Type | Devices |
| 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.
Lot / 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 from Philips Electronics North America Co...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0614-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Softw... | Nov 15, 2018 |
| Z-0592-2019 | Class II | IntelliVue MX40 Patient Monitor, Model Nos. 865... | Oct 10, 2018 |
| Z-3227-2018 | Class II | Allura Xper F010, System Code 722003 Vascul... | Jul 16, 2018 |
| Z-3218-2018 | Class II | INTEGRIS SUITE, System Code 722199 Vascular... | Jul 16, 2018 |
| Z-3215-2018 | Class II | INTEGRIS CV, System Code 722030 Vascular, c... | Jul 16, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.