Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. M
Summary
The FDA issued a Class II for Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indi by Philips North America Llc. Reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit.
Details
Source
Device Recall
External ID
Z-1853-2024
Action Date
2024-05-29
Status
Ongoing
Category
device
Product Description
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
Lot/Code Info: UDI-DI: N/A Serial Number: 30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252 30268 30028 30038 30058 30069 30081 30095 30100 30117 30118 30138 30164 30167 30168 30169 30170 30192 30197 30207 30209 30217 30228 30246 30248 30249 30256 30262 30267 30281 30284 30289 30297 30298 30306 30307 30312 30314 30210 30219 30245 30254 30276 30029 30043 30052 30061 30083 30101 30107 30114 30115 30116 30119 30120 30122 30130 30137 30140 30153 30154 30158 30159 30160 30163 30173 30174 30177 30178 30179 30196 30203 30251 30253 30259 30265 30266 30277 30279 30280 30282 30285 30291 30293 30104 30105 30216 30244 30290 30308 30316 30070 30208 30102 30112 30133 30206 30214 30224 30238 30261 30264 30274 30295 30303 30051 30084 30149 30215 30227 30232 30233 30234 30235 30035 30055 30143 30148 30272 30288 30294 8281 30304 30142 30218 30109 30131 30063 30091 30094 30202 30059 30099 30175 30176 30198 30237 30263 30269 30270 30302 30309 8002 8143 8122 8855 8404 30053 30075 30145 30064 30065 30123 30171 30085 30190 30226 30230 30231 30213 30135 30152 30155 30180 30181 30182 30183 30184 30185 30186 30187 30189 30220 30221 30223 30243 30250 30283 30310 30311 30017 30030 30047 30098 10193
Quantity Affected: 200 units
Reason for Recall
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-03
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 291 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1853-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29