GE OEC Medical Systems, Inc recalls OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which…
Read the official notice →- Date
- 2023-08-09
- Country
- United States
- Brand
- GE OEC Medical Systems
- Product
- OEC Flexiview 8800 Systems with 9-inch Image Intensifier
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More GE OEC Medical Systems recalls
- 2024-12-25
USGE OEC Medical Systems, Inc recalls OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to…
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
FDA · DeviceGE OEC Medical Systems, IncU.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice →
Other drugs & medical recalls in the United States
- 2023-08-09
- US
Covidien, LLC recalls Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction,…
FDA · DeviceCovidien, LLCWorldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the…Official notice → - US
Abiomed, Inc. recalls Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the…
FDA · DeviceAbiomed, Inc.US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA,…Official notice → - US
Hamamatsu Corporation recalls NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates…
If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.
- US
Maquet Cardiovascular, LLC recalls ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Bangladesh,…Official notice → - US
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa…
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to…
FDA · DeviceSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONU.S. Nationwide distribution.Official notice → - US
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical…
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN,…Official notice →