Pyxis MedStation
Pyxis MedStation Dispensing System cabinet, table and tray, anesthesia
22manufacturers in China registered for this device type
1catalogue number
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (5), Hebei (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei Yinkang Medical Equipment Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 8 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| China (Shenyang) MED-Land IMP/EXP Corp., Ltd. | Shanghai | Shanghai | Exporter | 32 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
| Shenzhen WAP-Health Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 16 |
Showing 12 of 22. All 22 manufacturers in China registered for Cabinet, Table And Tray, Anesthesia
Record
| Listed by | CareFusion 303, Inc, United States |
|---|---|
| FDA product code | BRY |
| Device type | Cabinet, Table And Tray, Anesthesia |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-07-23 |
| Record revised | 2026-06-11 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SW-MS-ES-V48 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pyxis Pro MedStation | CareFusion 303, Inc | 180 |
| BD Pyxis | CareFusion 303, Inc | 33 |
| Starsys® | Intermetro Industries Corp | 6 |
| Pyxis | CareFusion 303, Inc | 6 |
| Hospital Trolley | Resmed PTY Ltd. | 4 |
| Flexline® | Intermetro Industries Corp | 3 |
| laryngo-sheath | General Hospital Supply Corp. | 3 |
| ResMed | Resmed PTY Ltd. | 2 |
| Homecare | Resmed PTY Ltd. | 2 |
| APA IP Shield™ VL | Venner Medical (Singapore) PTE Ltd | 1 |
| XT Anesthesia Workstation (AWS) | Omnicell, Inc. | 1 |
| IntelliGuard® Anesthesia | IntelliGuard Group, LLC | 1 |
Showing 12 of 15. All products under Cabinet, Table And Tray, Anesthesia
Recalls
39 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 465 units |
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 1 unit |
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 114 units |
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 1 unit |
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 607 units |
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 709 units |
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 4,579 units |
| 2026-04-30 | Class II | Component design/selection | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | 15,933 |
| 2025-12-03 | Class II | Under Investigation by firm | Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. | 2,079 systems |
| 2025-11-20 | Class II | Device Design | Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead | 53669 |
| 2025-09-30 | Class II | Under Investigation by firm | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. | 443 units |
| 2025-09-30 | Class II | Under Investigation by firm | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. | 2,755 units |
| 2025-09-30 | Class II | Under Investigation by firm | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. | 27 units |
| 2025-09-30 | Class II | Under Investigation by firm | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. | 32 units |
| 2025-09-30 | Class II | Under Investigation by firm | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. | 8,262 units |
| 2025-07-10 | Class III | Use error | Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow. | 6076 |
| 2025-05-08 | Class II | Under Investigation by firm | Antivirus software was not consistently installed on impacted devices during the implementation process. | 8353 devices (6738 U.S. and 1615 O.U.S.) |
| 2025-05-08 | Class II | Software Design Change | During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software applica | 6,332 |
| 2025-03-11 | Class II | Software design | Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in | 7,357 |
| 2025-03-11 | Class II | Device Design | Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message “Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance”. | 404 systems |
| 2025-03-11 | Class II | Software design | Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more time | 7357 |
| 2025-02-06 | Class II | Software design | Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconne | 727 |
| 2025-01-23 | Class II | Nonconforming Material/Component | Due to fingerprint scanner failing resulting in the scanner heating up. | 229 MedFlex and 3,154 spare Bio-ID spare parts |
| 2025-01-10 | Class II | Labeling design | Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potent | 1521 |
| 2025-01-08 | Class II | Under Investigation by firm | Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. | |
| 2025-01-08 | Class II | Software design | Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues | 137,741 total |
| 2025-01-08 | Class II | Under Investigation by firm | Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. | |
| 2025-01-08 | Class II | Under Investigation by firm | Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. | |
| 2025-01-08 | Class II | Labeling design | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation. | 193067 |
| 2025-01-08 | Class II | Under Investigation by firm | Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. | 6,075 units |
| 2024-11-14 | Class II | Software design | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in e | 218 |
| 2024-11-14 | Class II | Software design | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in e | 40,763 |
| 2024-11-14 | Class II | Software design | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in e | 98,526 |
| 2024-07-09 | Class II | Software design | Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label. | |
| 2024-07-09 | Class II | Software design | Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label. | 3 units |
| 2024-06-24 | Class II | Under Investigation by firm | Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label. | 3 units |
| 2024-06-24 | Class II | Under Investigation by firm | Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label. | 1 unit |
| 2024-06-24 | Class II | Under Investigation by firm | Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label. | 16 units |
| 2024-06-24 | Class II | Under Investigation by firm | Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label. | 5 units |
| 2024-06-24 | Class II | Under Investigation by firm | Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label. | 84 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.