Olympus Corporation of the Americas recalls Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a…
Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the…
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging…
- Classification
- Class II
- Units
- OH
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Olympus Corporation of the Americas recalls
- 2024-11-20
USOlympus Corporation of the Americas recalls Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX,…
Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →- US
Olympus Corporation of the Americas recalls Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product…
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - 2024-11-06
- US
Olympus Corporation of the Americas recalls Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
- US
Olympus Corporation of the Americas recalls Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
- 2024-10-30
- US
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate…
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon,…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
Other drugs & medical recalls in the United States
- 2024-11-06
- US
Covidien LP recalls Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm…
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
FDA · DeviceCovidien LPWorldwide Distribution: US (Nationwide) and OUS (foreign) to countries of:…Official notice → - US
Integra LifeSciences Corp. recalls SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of…
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
FDA · DeviceIntegra LifeSciences Corp.Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great…Official notice → - US
Abbott Molecular, Inc. recalls Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay…
FDA · DeviceAbbott Molecular, Inc.Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA,…Official notice → - US
ImaCor Inc. recalls ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number:…
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
- US
Physio-Control, Inc. recalls LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o…
Due to an out of tolerance tool being used on monitor/defibrillator systems.
- US
Olympus Corporation of the Americas recalls Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.