GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardi
FDA device recall Z-1163-2014 · posted 2014-03-10 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction " letter dated December 10, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the Safety Issue, The long term solution is to provide a software correction for all of the affected systems that were distributed. The plan for public warning is to contact all customers with an affected system by means of an Urgent Medical Device Correction letter within the US. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to the following titles within the affected accounts: GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 For other countries, please contact your local GE Healthcare Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 257(159 US, 98 OUS)
- 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,
- Date initiated
- 2013-12-11
- Date posted
- 2014-03-10
- Date terminated
- 2014-07-29
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 2100 (K050489) | Ge Medical Systems, LLC | 2005-03-11 |
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |
| DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION (K033244) | Ge Medical Systems, Inc. | 2003-10-16 |
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |
| INNOVA 4100 (K023178) | Ge Medical Systems, Inc. | 2002-11-26 |