---
title: "Digital Angiography System Bransist safire Generator Model D150GC-40 — FDA record Z-0654-2022 | Is It on Recall"
description: "Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray rad"
url: https://isitonrecall.com/recall/fda-device-z-0654-2022-digital-angiography-system-bransist-safire-generator-model-d150gc-40/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Digital Angiography System Bransist safire Generator Model D150GC-40 — FDA record Z-0654-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 16, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Digital Angiography System Bransist safire Generator Model D150GC-40
- **Reason**: Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
- **Classification**: Class II
- **Recalling firm**: Shimadzu Medical Systems
- **Quantity**: 18
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0654-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0654-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Generator Model: D150GC-40 Serial Number Range - 0161Q81103 to 3M99D3A55001 Specific Generator Serial Number/SMS ID: 3M99D3A24001/SMS20120038 3M99D3A4B001/SMS20140084 3M99D3A55001/SMS20150030 0161Q83701/SMS20080542 0161Q82204/SMS20080045 0161Q82302/SMS20080043 0161Q82304/SMS20080046 0261Q80901/SMS20100011 3M7A1600B001/SMS20080286 3M99D2622001/SMSMA110079 0161Q84501/SMS20090038 3M7A1600C001/SMS20200285 3M7A16A1A001/SMSMA110013 3M99D3A1C001/SMS20110202 0161Q84103/SMS20090099 0161Q83603/SMS20080505 0161Q83702/SMS20080580 0161Q83703/SMS20080581 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.: CA, FL, GA, IL, IN, KY, LA, MI, MS, OH, PA, SC, TN, TX and WA O.U.S.: Not provided.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Mar 9, 2022
- **Recall initiation date**: Dec 16, 2021
- **Center classification date**: Feb 27, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0654-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Shimadzu Medical Systems records](https://isitonrecall.com/brand/shimadzu-medical-systems/)