GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling Discovery MR450, Discovery MR750, and Optima MR450w magnetic resonance imaging scanners due to exposed yellow foam on the end bells of affected units. The yellow foam strip, which sits between the end bell covers and patient bore, may extend past the surface of the covers on certain scanners. While the foam itself is not hazardous, the concern is that fluids or body substances could be absorbed by the exposed foam.
A total of 828 scanners have been distributed worldwide, including 443 in the United States and 385 internationally across numerous countries. The recall affects specific serial numbers listed in the distribution record. The source does not specify a remedy or corrective action for affected consumers or facility operators.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed
Reason for recall: GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed Distribution: Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Martinique, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Ru Quantity: 828 (443 US, 385 OUS) Lot/code info: Mfg Lot or Serial # 00000029854MR5 00000288907MR9 00000289309MR7 00000289310MR5 00000289961MR5 00000290050MR4 00000290137MR9 00000290202MR1 00000290457MR1 00000290502MR4 00000290659MR2 00000290773MR1 00000290957MR0 00000291185MR7 00000291325MR9 00000291363MR0 00000291397MR8 00000291464MR6 00000291489MR3 00000292367MR0 00000292471MR0 00000292528MR7 00000292634MR3 00000292843MR0 00000293065MR9 00000293874MR4 00000294098MR9 00000294398MR3 00000294472MR6 00000294556MR6 00000294576MR4 00000294718MR2 00000295111MR9 00000295134MR1 00000295215MR8 00000296070MR6 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296300MR7 00000296369MR2 00000296429MR4 00000296462MR5 00000296469MR0 00000296626MR5 00000296829MR5 00000296840MR2 00000296841MR0 00000296860MR0 00000297134MR9 00000297147MR1 00000297355MR0 00000297387MR3 00000297493MR9 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298114MR0 00000298247MR8 00000298248MR6 00000298249MR4 00000298310MR4 00000298386MR4 00000298387MR2 00000298494MR6 00000298512MR5 00000298535MR6 00000298552MR1 00000298573MR7 00000298574MR5 00000298655MR2 00000298656MR0 00000298675MR0 00000298722MR0 00000298727MR9 00000298834MR3 00000298836MR8 00000298861MR6 00000298869MR9 00000298870MR7 00000298889MR7 00000298901MR0 00000298932MR5 00000298943MR2 00000298959MR8 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299199MR0 00000299200MR6 00000299230MR3 00000299264MR2 00000299294MR9 0000029932
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.