DX-D 100 · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2024-02-23	Z-1462-2024	Class II	Open, Classified	Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injuryDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Argentina, Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom.	541 units	clearance family
2016-01-20	Z-1698-2017	Class II	Terminated	The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.Distribution: Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.	308	clearance family
2015-05-29	Z-1745-2015	Class II	Terminated	When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.Distribution: US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.	233 units	clearance family
2014-06-06	Z-2081-2014	Class II	Terminated	When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.Distribution: USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada.	216 units	clearance family
2014-05-13	Z-2176-2014	Class III	Terminated	Unit was mislabeled with a factory label showing 32 KW output power.Distribution: US in the state of WV	1	clearance family
2013-05-15	Z-1487-2013	Class II	Terminated	Customers could potentially experience intermittent, unintended and illogical movement when using the product.Distribution: Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada	104	clearance family

Regulatory clearances

510(k)K103597Substantially equivalent (SESE) · 2011-01-03clearance family

Predicate lineage

K103597

Cited as predicate by: K141602, K161368, K172784, K180589, K183275, K191884, K193262, K212145, K213469

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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