GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in gene
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling certain Innova cardiovascular X-ray imaging systems (models 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ, and 3131IQ) due to a potential safety issue where the systems can unexpectedly stop delivering X-rays following a power-on or reset cycle. This loss of real-time interventional imaging could disrupt procedures. The recall affects 257 systems worldwide, including 159 in the United States and 98 outside the U.S. across numerous countries and states. No injuries have been reported as a result of this issue.
The record does not specify what affected consumers or healthcare facilities should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue.
Reason for recall: GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue. Distribution: Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MS, MO, NV, NJ, NY, NC, ND, OH, OK OR, PA, PR, RI, SC, TN, TX, UT, VA,WA,WY and WI., and the countries of ARGENTINA, AUSTRALIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KO Quantity: 257(159 US, 98 OUS) Lot/code info: Mfg Lot or Serial # System ID 00000550134BU1 2035763100A 00000581573BU3 203932VA4100 00000523132BU9 205783BCL5 00000560743BU7 206598UWBP 00000446090BU3 207351YCL1 00000504213BU0 212305CATH1 00000437215BU7 214324INNOVA2 00000562417BU6 2198864100 00000093723VE5 229228INNOV21C 00000583484BU1 240566CATH2 00000478109BU2 251435ICV3 00000477896BU5 3016094100 00000441137BU7 3018774100 00000466659BU0 303788CL1 00000466984BU2 304424INNOVA 00000445301BU5 309691P3100 00000424103BU0 310423INNOVA1 00000579612BU3 313745IN1 00451726BU4BU8 316268INNOVAA 00000466810BU9 318449INNOVA2 00000482326BU6 3184734100 00000499386BU1 330375LAB2 00000445906BU1 334286BSP 00000551081BU3 336832MCCL6 00000464558BU6 352333CATH2 00000463833BU4 361980INNOVA2 00000427056BU7 401274IN41 00000585912BU9 404712SP11 00000585915BU2 405271P4100 00000593051BU6 405610MWC3100EP 00000449428BU2 405840OIC3100 00000541272BU1 407518EP 00000431502BU4 407518SP3 00000452126BU6 407SPECIALS 00000490443BU9 408559INV1 00000421698BU2 4103374100 00000461599BU3 410337INNOVA6 00000571721BU0 410368INNOVA1 00000442436BU2 4105434100 00000533867BU8 410554INNOVA1 00000548841BU6 410554INNOVA4 00000560325BU3 410614CV1 00000443912BU1 412623LAB3 00000454264BU3 419251LAB1 00000576989BU8 423493CL1 00000450075BU7 480821IN2 00000468193BU8 501257VALAB1 00000434782BU9 502587LAB4 FMI12204DUMM03 508383IN4100 00000581740BU8 509473RM1 00000459476BU8 5135844100 00000415698BU0 5136864100 00000479625BU6 516562INNOVA5A 00000460641BU4 516562INNOVA6 00000460969BU9
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.