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Artis Q.zen ceiling, Model Number 10848354 recallZ-0979-2022 · Siemens Medical Solutions USA, Inc · initiated Feb 23, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

FDA root cause category: Device Design

What the company is doing

An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 2/23/22 was sent to customers. Which steps have to be taken by the user to avoid the possible risks associated with this problem? As also described in the Operator Manual, we recommend that the system operator checks the water level of the cooling circuit at least every three months and refills water, if necessary: 1. Open the filling gland of the cooling unit. The water surface must be clearly visible above the cooling ribs. 2. Replenish with water (drinking water quality) if cooling liquid is lacking. Please inform the service technician in case of lacking cooling liquid. How will the corrective action be implemented and what is the efficiency of the corrective actions? The tube cooling unit will be equipped with a water level sensor and the software will be updated accordingly. In case the coolant level drops below a certain threshold the following message will be displayed: Tube cooling water level low: Refill as per Operator Manual . Siemens will correct the error with a hardware and software update via Update Instruction AX002/20/S and AX004/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. We do not consider it necessary to re-examine any patients in relation to the issues described above. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. If you have received this notification by email via Adobe EchoSign, kindly sign with your digital signature to acknowledge that you have read and understand t

Recall details

Recall number
Z-0979-2022
Status
Open, Classified
Initiated by the company
Feb 23, 2022
Posted by the FDA
Apr 21, 2022
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
81 systems
Product code
OWB
FDA submissions
K181407
Distribution
US Nationwide.

Product description

Artis Q.zen ceiling, Model Number 10848354

Code information (models, lots, serial numbers)

UDI: 4056869010021; Serial Numbers: 111160 111162 111163 111137 111502 111139 111174 111185 111503 111005 111002 111145 111176 111510 111155 111179 111140 111507 111122 111168 111170 111173 111512 111141 111508 111521 111133 111003 111111 111103 111101 111011 111182 111184 111143 111150 111164 111183 111504 111149 111109 111151 111129 111121 111130 111517 111513 111017 111010 111115 111116 111117 111119 111104 111148 111127 111175 111506 111112 111131 111132 111134 111158 111167 111157 111161 111142 111156 111500 111501 111169 111505 111166 111107 111514 111000 111106 111123 111128 111135 Additional Serial Numbers as of 10/4/23: 111125

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

11 devices cleared under K181407 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89860).

Sources and updates

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