Ziehm Imaging Inc: Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Recall number

Z-0567-2014

Recalling firm

Ziehm Imaging Inc

Product

Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Status

Terminated

Initiated

2013-11-21

Posted

2013-12-24

Terminated

2014-06-23

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.

Root cause

Device Design

Action

Ziehm Imaging sent an "URGENT RECALL NOTICE" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. Customers were advised and instructed to: Your Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility. Recall of the product was initiated because according to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device for vertical travel of the c-arm imaging assembly. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device identification and label. The issue: According to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device. The manufacturer Ziehm Imaging GmbH advised customers they may continue to operate the affected device with caution until the correction has been carried out on-site. During this time Ziehm Imaging GmbH advises the operator to be aware of the following safety measures which may resolve the possibility of potentially hazardous situations by: " Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart " Removing the power cable from the wall outlet or, " Activate the push-buttons for reverse vertical movement and keeping the pushbutton pressed until patient /operator is no longer in the risk zone or the device stops Please alert all staff members working with the device to these potential hazardous situations, and familiarize them with all possibilities to resolve the hazardous situation

Quantity

103 devices

Distribution

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.

Lot, serial or model codes

10016 10070 10135 10153 10235 10485 10026 10071 10092 10154 10260 10486 10028 10072 10093 10155 10265 10488 10030 10073 10094 10156 10266 10489 10031 10074 10109 10162 10396 10490 10038 10075 10111 10181 10431 10491 10042 10076 10117 10192 10434 10510 10045 10078 10118 10196 10435 10519 10046 10080 10119 10197 10436 10520 10048 10081 10121 10198 10443 10521 10049 10082 10122 10202 10457 10524  10053 10083 10123 10207 10458 10525 10054 10086 10124 10209 10459 10528 10056 10087 10125 10214 10460 10066 10088 10126 10215 10462 10067 10089 10127 10216 10472 10068 10090 10131 10223 10476 10069 10091 10134 10233 10484

510(k) numbers

["K061203"]

PMA numbers

not on file

Product code

OWB

Firm FEI

2027299

Firm city

Orlando

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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