CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report

Bucky Stand SU-4000 Input recalled by Konica Minolta Healthcare

Konica Minolta Healthcare, Americas is recalling Bucky Stand SU-4000 Input 2017.11.17, distributed nationwide in the US. The recall was initiated on 8 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSU4000 AU 4000 U ARM Item Number DR-4000-MTB Serials Numbers/Lot Numbers: SU41607003; SU41607004; SU41607005; SU41607006; SU41607008; SU41607009; SU41607010; SU41607011; SU41612012; SU41612013; SU41612014; SU41612015; SU41612016; SU41612017; SU41612018; SU41612019; SU41612020; SU41612021; SU41702006; SU41702007; SU41702009; SU41703010; SU41703011; SU41703012; SU41703013; SU41703015; SU41704016; SU41704017; SU41704019; SU41704020; SU41704021; SU41704022; SU41704023; SU41704024; SU41704025; SU41705026; SU41705027; SU41705028; SU41705029; SU41705031; SU41705032; SU41705033; SU41705034; SU41705035; SU41707036; SU41707038; SU41707039; SU41707040; SU41707041; SU41707042; SU41707043; SU41707044; SU41708046; SU41708047; SU41708048; SU41708049; SU41708050; SU41708051; SU41708052; SU41708053; SU41708054; SU41708055; SU41709060; SU41709061; SU41709062; SU41709063; SU41709064; SU41709065; SU41709066; SU41709068; SU41709069; SU41711070; SU41711071; SU41711072; SU41711073; SU41711074; SU41711075; SU41711076; SU41711077; SU41711079; SU41711080; SU41711081; SU41711082; SU41711083; SU41711084; SU41711085; SU41711086; SU41711087; SU41711088; SU41711089; SU41712090; SU41712093; SU41712094; SU41712095; SU41712096; SU41712097; SU41712098; SU41712099; SU4172091; SU41801001; SU41801002; SU41801003; SU41801004; SU41801005; SU41802006; SU41802007; SU41802008; SU41802009; SU41802010; SU41802011; SU41802012; SU41802013; SU41802014; SU41802015; SU41802016; SU41802017; SU41802018; SU41802019; SU41802020; SU41803021; SU41803022; SU41803023; SU41803024; SU41803025; SU41803026; SU41803028; SU41803029; SU41803030; SU41803031; SU41803032; SU41803033; SU41803034; SU41803035; SU41803037; SU41803038; SU41803039; SU41803040; SU41806041; SU41806042; SU41806043; SU41806044; SU41808047; SU41808048; SU41808049; SU41808050; SU41808053; SU41808054; SU41808055; SU41808058; SU41808060; SU41808063; SU41808064

Quantity recalled151

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0659-2019
FDA event ID: 81649
Recalling firm: Konica Minolta Healthcare, Americas, Garner, NC
Classification: Class II
Status: Terminated
Recall initiated: 8 Nov 2018
FDA classified: 20 Dec 2018
Reported: 26 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

8 Nov 2018	Recall initiated by company
20 Dec 2018	Classified by FDA	+42 days
26 Dec 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unintentional U-Arm movement

Product as listed by the FDA

Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.

Where it was distributed

US Nationwide Distribution: AL; CA; CO; FL; GA; IA; IL; IN; KY; LA; MA; MI; MN; MO; NC; NH; NY; OH; OK; PA; SC; TN; TX; and VA.

Nationwide Alabama California Colorado Florida Georgia Iowa Illinois Indiana Kentucky Louisiana Massachusetts Michigan Minnesota Missouri North Carolina New Hampshire New York Ohio Oklahoma Pennsylvania

Questions about this recall

Is Bucky Stand SU-4000 Input 2017.11.17 recalled?

Yes. Konica Minolta Healthcare, Americas recalled Bucky Stand SU-4000 Input 2017.11.17 on 8 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0659-2019.

Why was it recalled?

Unintentional U-Arm movement

Which lots are affected?

SU4000 AU 4000 U ARM Item Number DR-4000-MTB Serials Numbers/Lot Numbers: SU41607003; SU41607004; SU41607005; SU41607006; SU41607008; SU41607009; SU41607010; SU41607011; SU41612012; SU41612013; SU41612014; SU41612015; SU41612016; SU41612017; SU41612018; SU41612019; SU41612020; SU41612021; SU41702006; SU41702007; SU41702009; SU41703010; SU41703011; SU41703012; SU41703013; SU41703015; SU41704016; SU41704017; SU41704019; SU41704020; SU41704021; SU41704022; SU41704023; SU41704024; SU41704025; SU41705026; SU41705027; SU41705028; SU41705029; SU41705031; SU41705032; SU41705033; SU41705034; SU41705035; SU41707036; SU41707038; SU41707039; SU41707040; SU41707041; SU41707042; SU41707043; SU41707044; SU41708046; SU41708047; SU41708048; SU41708049; SU41708050; SU41708051; SU41708052; SU41708053; SU41708054; SU41708055; SU41709060; SU41709061; SU41709062; SU41709063; SU41709064; SU41709065; SU41709066; SU41709068; SU41709069; SU41711070; SU41711071; SU41711072; SU41711073; SU41711074; SU41711075; SU41711076; SU41711077; SU41711079; SU41711080; SU41711081; SU41711082; SU41711083; SU41711084; SU41711085; SU41711086; SU41711087; SU41711088; SU41711089; SU41712090; SU41712093; SU41712094; SU41712095; SU41712096; SU41712097; SU41712098; SU41712099; SU4172091; SU41801001; SU41801002; SU41801003; SU41801004; SU41801005; SU41802006; SU41802007; SU41802008; SU41802009; SU41802010; SU41802011; SU41802012; SU41802013; SU41802014; SU41802015; SU41802016; SU41802017; SU41802018; SU41802019; SU41802020; SU41803021; SU41803022; SU41803023; SU41803024; SU41803025; SU41803026; SU41803028; SU41803029; SU41803030; SU41803031; SU41803032; SU41803033; SU41803034; SU41803035; SU41803037; SU41803038; SU41803039; SU41803040; SU41806041; SU41806042; SU41806043; SU41806044; SU41808047; SU41808048; SU41808049; SU41808050; SU41808053; SU41808054; SU41808055; SU41808058; SU41808060; SU41808063; SU41808064

Where was it sold?

US Nationwide Distribution: AL; CA; CO; FL; GA; IA; IL; IN; KY; LA; MA; MI; MN; MO; NC; NH; NY; OH; OK; PA; SC; TN; TX; and VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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