Device Recall Olympus

Manufacturer

  • Manufacturer Address
    Integrated Medical Systems Inc, 3200 2nd Ave N, Birmingham AL 35222-1212
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

36 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot numbers: 075W, 076W, 077W, 078W, 081W, 083W, 084W, 07XW, and 07YW
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada
  • Product Description
    Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L || Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic and therapeutic tools through the abdominal wall.
  • Manufacturer
  • Model / Serial
    Snare Package Lot numbers: 9YK, 9ZK, 01K, 02K, & 03K.  Snare Tube Lot Numbers: K9Y10, K9Y16, K9Y18, K9Y19, KDY20, K9Y24, K9Y25, K9Y26, K9Y27, K9Y30,K9Z01, K9Z02, K9Z03, K9Z04, K9Z07, K9Z08, K9Z09, K9Z10, K9Z11, K9Z14,K9Z15, K9Z16, K9Z17, K9Z18, K9Z21, K9Z22, K9Z24, K9Z25, K9Z28, K9Z29, K0105, K0106, K0107, K0108, K0112, K0113, K0114, K0115, K0118, K0119, K0120, K0121, K0122, K0127, K0129, K0202, K0203, K0204, K0205, K0208, K0209, K0210, K0212, K0215, K0216, K0217, K0218, K0222, K0224,K0225, K0226, K0301, K0302, K0303, K0305, K0308, K0309, K0310, K0311, K0312, K0315, and K0316.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX.
  • Product Description
    Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. || To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.
  • Manufacturer
  • Model / Serial
    Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe
  • Product Description
    Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
  • Manufacturer
  • Model / Serial
    All lot numbers of Pediatric knives: Model numbers A37008A, A37009A, A37010A and Pediatric HF resection electrodes: Model numbers A37011A, A37012A, A37013A.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AL, AR, CA, CO, CT, FL, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OR, TX, VA, VT, and WI.
  • Product Description
    OLYMPUS Pediatric Knives and Resection Electrodes || The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.
  • Manufacturer
  • Model / Serial
    Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. || Mobile X-ray System.
  • Manufacturer
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