510(k) K151570 ยท BSZ Gas-Machine, Anesthesia
Carestation 620/650/650C
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | Jun 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151570
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system, product number and REF numbers:
Carestation 610 A1, REF 1012-9620-222;
Carestation 620 A1 REF 1012-9620-000;
Carestation 620 A1, REF 1012-9620-200;
C Open, Classified |
BSZ | None listed |
| Dec 18, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. Open, Classified |
BSZ | None listed |
| Apr 29, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. Open, Classified |
BSZ | None listed |
| Jan 23, 2020 | GE Healthcare, LLC Carestation 620/650/650c A1
Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. Terminated |
BSZ | None listed |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems Terminated |
BSZ | None listed |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE Carestation 30 anesthesia systems Terminated |
BSZ | None listed |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE 9100c NXT anesthesia systems Terminated |
BSZ | None listed |
| Oct 11, 2017 | GE Medical Systems China Co., Ltd. Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Open, Classified |
BSZ | None listed |
| May 24, 2017 | GE Healthcare, LLC Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.