Stretcher, Wheeled(FPO)
車輪付きストレッチャー この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
75 件
直近 2025.10.22
50 件
0 件
35,245 件
分類情報
| Product Code | FPO |
|---|---|
| デバイス名 | Stretcher, Wheeled 車輪付きストレッチャー この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス II |
| 21 CFR 規制番号 | 880.6910 |
| 審査区分 | 届出免除(510(k) Exempt) |
| 医療専門分野 | 一般病院用 |
| 定義 | - |
| フラグ | 該当なし |
| AI分析 | 車輪付きストレッチャーは、患者を仰臥位のまま搬送するための車輪付き移動式の医療機器です。米国ではクラスIIに分類されますが、リスクが比較的低いと判断されているため510(k)の市販前届出が免除されており、届出を行わずに販売することが可能です。 米国市場での動向 510(k)は累計50件、参入企業32社に上りますが、直近5年の届出は0件で最新の判断は2011年12月であり、PMAの実績はありません。不具合報告は累計約35,200件で、大半が不具合(Malfunction)であり、死亡は108件、傷害は約1,200件です。直近5年は約4,300件で、主な問題としてUnintended Movement(意図しない動作)、Mechanical Jam(機械的な引っかかり)、Mechanical Problem(機械的問題)が挙げられています。回収は累計約80件で、クラスIは確認されていない一方、クラスIIが23件、直近5年では7件、最新の回収開始は2026年6月です。 この分析は公開データ(openFDA・JMDN 対応情報)をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
FDA のデバイスクラスは 3 段階(クラス I〜III)、日本の医療機器は 4 段階(クラス I〜IV)で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 75 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-0133-2026 FPO | クラス II | 2025.09.11 | Ferno-Washington Inc | The fastening post hardware could loosen allowing the fastening post to detach from the cot | 対応中 |
| Z-2130-2023 FPO | クラス II | 2023.05.24 | Stryker Medical Division of Stryker Corporation | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion. | 対応中 |
| Z-1256-2023 FPO | クラス II | 2023.02.01 | Stryker Medical Division of Stryker Corporation | Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport. | 対応中 |
| Z-1211-2023 FPO | クラス II | 2023.01.18 | Linet Spol. S.r.o. | Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury. | 対応中 |
| Z-0479-2023 FPO | クラス II | 2022.11.11 | Stryker Medical Division of Stryker Corporation | Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected. | 対応中 |
| Z-0184-2023 FPO | クラス II | 2022.10.07 | Ferno-Washington Inc | Batteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may result in a fire and/or injury | 対応中 |
| Z-2208-2021 FPO | クラス II | 2021.05.12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | 対応中 |
| Z-2207-2021 FPO | クラス II | 2021.05.12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | 対応中 |
| Z-2205-2021 FPO | クラス II | 2021.05.12 | Stryker Medical Division of Stryker Corporation | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | 対応中 |
| Z-1350-2019 FPO | クラス II | 2018.11.20 | Stryker Medical Division of Stryker Corporation | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. | 終了 |
| Z-1389-2018 FPO | クラス II | 2018.03.12 | Stryker Medical Division of Stryker Corporation | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. | 終了 |
| Z-1599-2018 FPO | クラス II | 2018.03.09 | Stryker Medical Division of Stryker Corporation | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. | 終了 |
| Z-1598-2018 FPO | クラス II | 2018.03.09 | Stryker Medical Division of Stryker Corporation | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. | 終了 |
| Z-1827-2017 FPO | クラス II | 2017.03.08 | Ferno-Washington Inc | The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. | 終了 |
| Z-0739-2017 FPO | クラス II | 2016.11.08 | Stryker Medical Division of Stryker Corporation | Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers. | 終了 |
| Z-1990-2016 FPO | クラス II | 2016.05.05 | Stryker Medical Division of Stryker Corporation | Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. In addition to the alleged smoking, one of the reports had also noted that when the user attempted to lower the cot (prior to the alleged smoking) the device went into high speed retract and then a few moments later i | 終了 |
| Z-1185-2016 FPO | クラス II | 2016.02.05 | Stryker Medical Division of Stryker Corporation | The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we | 終了 |
| Z-2826-2015 FPO | クラス II | 2015.08.03 | Ferno-Washington Inc | Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame. | 終了 |
| Z-1939-2015 FPO | クラス II | 2015.06.01 | Sechrist Industries Inc | Sechrist Industries is recalling the Sechrist Low Profile Wheeled Stretcher because it may experience an unexpected incline angle during the height adjustment of the Low Profile Wheeled Stretcher when lifting the patient upward or when lowering the Wheeled Stretcher to a height at which the patient can be loaded/unloaded. | 終了 |
| Z-2461-2015 FPO | クラス II | 2015.05.01 | Ferno-Washington Inc | The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use. | 終了 |
510(k)(市販前届出)
全 50 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K113598 | POWER-LOAD COT FASTENER SYSTEM | Stryker Medical | 2011.12.20 | 通常(Traditional) | |
| 2 | K072598 | IRSG I-MOVER FOR BEDS | International Retail Services Group, LLC | 2008.04.14 | 通常(Traditional) | |
| 3 | K972528 | DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) | Dyna Corp. | 1997.07.28 | 通常(Traditional) | - |
| 4 | K955766 | ADULT-PEDIATRIC TRANSPORT SYSTEM | International Biomedical, Inc. | 1996.08.07 | 通常(Traditional) | - |
| 5 | K962181 | HARE MODEL 2000 EZ LOADER MODEL 95555 | Dyna Corp. | 1996.08.01 | 通常(Traditional) | - |
| 6 | K961437 | WHEELED STRETCHER | Hill-Rom, Inc. | 1996.06.03 | 通常(Traditional) | |
| 7 | K952447 | HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER | Hill-Rom, Inc. | 1995.11.22 | 通常(Traditional) | - |
| 8 | K946101 | EMERGENCY/ACCIDENT TROLLEY 550 | Hogan & Hartson | 1995.02.07 | 通常(Traditional) | |
| 9 | K945431 | MODEL 792 CONVERGE, MODEL 793 VISION 2000 | Hausted, Inc. | 1995.01.25 | 通常(Traditional) | |
| 10 | K943969 | MODEL 578 MOBILE SURGICAL STRETCHER | Hausted, Inc. | 1995.01.25 | 通常(Traditional) | |
| 11 | K942948 | STRYKER POWERED STRETCHER | Stryker Corp. | 1995.01.24 | 通常(Traditional) | - |
| 12 | K943529 | PATIENT TROLLEY 540 | Merivaara Instrumentarium Corp. | 1994.10.04 | 通常(Traditional) | |
| 13 | K943528 | PATIENT TROLLEY 545 | Merivaara Instrumentarium Corp. | 1994.10.04 | 通常(Traditional) | |
| 14 | K943262 | FUTURA JUNIOR 300/310 | Merivaara Instrumentarium Corp. | 1994.09.29 | 通常(Traditional) | |
| 15 | K943864 | STRYKER 8000 SURGERY STRETCHER | Stryker Medical | 1994.08.25 | 通常(Traditional) | - |
| 16 | K935297 | STRYKER AMBULANCE COT MODEL 6060 | Stryker Medical | 1994.02.18 | 通常(Traditional) | - |
| 17 | K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER | Midmark Corp. | 1994.02.09 | 通常(Traditional) | - |
| 18 | K933060 | S-610 & 2-628 WHEELED SHOWER STRETCHERS | The Anthros Medical Group | 1994.02.04 | 通常(Traditional) | - |
| 19 | K933071 | STS 701 TRANSPORT STRETCHER | Wy'East Medical Corp. | 1994.01.26 | 通常(Traditional) | |
| 20 | K933366 | I.V. LINK | Deville Laboratories, Inc. | 1994.01.10 | 通常(Traditional) | - |
出典の openFDA は各 510(k) の主要(primary)product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA(市販前承認)
この product code の PMA 情報はありません。
不具合報告(MAUDE)トレンド
米国不具合報告検索で詳しく見る出典: openFDA(U.S. FDA) のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット(510(k)・PMA・MAUDE・回収・Warning Letter)の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA(U.S. FDA) のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット(510(k)・PMA・MAUDE・回収・Warning Letter)の解説は 米国FDA情報の概要 を参照してください。