FDA (Devices) recall action 88962

Siemens Medical Solutions USA, Inc recalled 10 products on 2021-12-01

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2021-12-01
Critical: 0
Units: 142

Why these products were recalled

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

ModerateFDA (Devices)··2021-12-01
Siemens Artis Q.zen Angiography System May Fail to Fire X-rays During Simultaneous Operations
Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.
Product
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Siemens Artis Zee Angiography System Software May Prevent X-Ray Activation
Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.
Product
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Siemens Artis zee x-ray system may delay imaging delivery during procedures
Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.
Product
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Medical Imaging System May Fail to Release X-rays Under Specific Conditions
Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.
Product
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Siemens Artis Q.zen Angiography System X-Ray Imaging Delay Issue
Siemens has recalled two Artis Q.zen angiography systems due to a software issue that may prevent x-ray imaging and delay procedures when SID lift and x-ray controls are activated simultaneously.
Product
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Siemens Artis Zee Biplane X-ray Imaging System Software Malfunction
Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, resulting in procedural delays.
Product
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094141
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Siemens Artis Q Biplane X-ray System Software Imaging Delay Issue
Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing procedural delay.
Product
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Siemens Artis Q floor angiography system: X-ray failure during SID lift operation
Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.
Product
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
Category
Distribution
0 states
ModerateFDA (Devices)··2021-12-01
Siemens Artis Q.zen Angiography System X-ray Activation Failure
Siemens is recalling 15 Artis Q.zen angiography systems that may fail to generate x-rays when the lift mechanism and x-ray release are activated simultaneously, potentially causing a procedural delay.
Product
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Category
Distribution
0 states
HighFDA (Devices)··2021-12-01
Siemens Artis Q angiography systems may fail to deliver x-ray during procedures
Siemens Artis Q angiography systems may fail to release x-ray when source-to-image distance lift and x-ray release are activated simultaneously, causing procedure delays.
Product
Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
Category
Distribution
0 states