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Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Penner Pacific Bathing Spa, Model Numbers 360020-1P Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Penner Pacific Bathing Spa, Model Numbers 360020-1EP Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X Class III

Reason: The device does not bear a unique device identifier.

Penner Patient Care, Inc. 20250813 Ongoing
Distributed: US Nationwide distribution.
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Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene. Class II

Reason: Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.

Raz Design Inc 20260105 Ongoing
Distributed: U.S. Nationwide distribution in the states of CO, FL, IL, MA, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, TX, WA, and WI.
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IBA Proton Therapy System - PROTEUS 235 Class II

Reason: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.

Ion Beam Applications S.A. 20260203 Ongoing
Distributed: Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
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