Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging Class II

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc 20131121 Terminated
Distributed: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging Class II

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc 20131121 Terminated
Distributed: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging Class II

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc 20131121 Terminated
Distributed: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging Class II

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc 20131121 Terminated
Distributed: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging Class II

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc 20131121 Terminated
Distributed: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging Class II

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc 20131121 Terminated
Distributed: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging Class II

Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Ziehm Imaging Inc 20131121 Terminated
Distributed: USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module Class II

Reason: Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l

Siemens Healthcare Diagnostics, Inc. 20130506 Terminated
Distributed: US Nationwide and OUS.
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures. Class III

Reason: Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the device was incorrect.

Edwards Lifesciences, LLC 20131120 Terminated
Distributed: Distributed to 3 customers in FL only.
B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system. Class II

Reason: One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

B. Braun Medical, Inc. 20130927 Terminated
Distributed: USA Nationwide Distribution including Puerto Rico.
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