Z-1217-2015 Class II Terminated
FDA device recall Z-1217-2015 was initiated by Arjo Hospital Equipment AB on December 3, 2014 and is designated Class II. Reason for recall: The recalled devices labeling and instructions for use contain unapproved medical claims. The recall status is terminated (terminated October 30, 2015). Affected quantity: 226 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2015
- Initiation Date
- December 3, 2014
- Termination Date
- October 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 226 units
Product Description
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
Reason for Recall
The recalled devices labeling and instructions for use contain unapproved medical claims.
Distribution Pattern
Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
Code Information
SERIAL NUMBERS: RRFK00041, RRFK00083, RRFK00232, RRFK00233, RRFK00276, RRFK00229, RRFK00215, RRFK00221, RRFK00243, RRFK00121, RRFK00263, RRFK00094, RRFK00150, RRFK00274, RRFK00103, RRFK00198, RRFK00256, RRFK00111, RRFK00290, RRFK00091, RRFK00044, RRFK00087, RRFK00241, RRFK00047, RRFK00186, RRFK00059, RRFK00170, RRFK00246, RRFK00064, RRFK00071, RRFK00289, RRFK00056, RRFK00078, RRFK00178, RRFK00051, RRFK00248, RRFK00155, RRFK00202, RRFK00247, RRFK00128, RRFK00228, RRFK00269, RRFK00126, RRFK00277, RRFK00207, RRFK00253, RRFK00067, RRFK00280, RRFK00108, RRFK00174, RRFK00161, RRFK00105, RRFK00125, RRFK00240, RRFK00052, RRFK00102, RRFK00147, RRFK00153, RRFK00082, RRFK00062, RRFK00225, RRFK00265, RRFK00070, RRFK00104, RRFK00123, RRFK00172, RRFK00085, RRFK00069, RRFK00190, RRFK00252, RRFK00287, RRFK00050, RRFK00119, RRFK00210, RRFK00239, RRFK00169, RRFK00191, RRFK00149, RRFK00168, RRFK00162, RRFK00226, RRFK00068, RRFK00284, RRFK00107, RRFK00227, RRFK00049, RRFK00166, RRFK00194, RRFK00196, RRFK00216, RRFK00148, RRFK00230, RRFK00266, RRFK00143, RRFK00097, RRFK00199, RRFK00223, RRFK00188, RRFK00101, RRFK00164, RRFK00037, RRFK00167, RRFK00192, RRFK00055, RRFK00086, RRFK00173, RRFK00177, RRFK00222, RRFK00238, RRFK00189, RRFK00038, RRFK00165, RRFK00099, RRFK00160, RRFK00141, RRFK00201, RRFK00043, RRFK00080, RRFK00112, RRFK00209, RRFK00124, RRFK00146, RRFK00042, RRFK00066, RRFK00184, RRFK00106, RRFK00224, RRFK00275, RRFK00180, RRFK00115, RRFK00251, RRFK00278, RRFK00237, RRFK00283, RRFK00219, RRFK00254, RRFK00179, RRFK00211, RRFK00127, RRFK00117, RRFK00157, RRFK00120, RRFK00073, RRFK00193, RRFK00195, RRFK00218, RRFK00096, RRFK00095, RRFK00204, RRFK00053, RRFK00282, RRFK00113, RRFK00200, RRFK00264, RRFK00118, RRFK00109, RRFK00122, RRFK00261, RRFK00244, RRFK00187, RRFK00039, RRFK00152, RRFK00181, RRFK00206, RRFK00231, RRFK00046, RRFK00093, RRFK00159, RRFK00088, RRFK00154, RRFK00076, RRFK00145, RRFK00175, RRFK00270, RRFK00065, RRFK00089, RRFK00054, RRFK00213, RRFK00040, RRFK00057, RRFK00156, RRFK00144, RRFK00249, RRFK00258, RRFK00045, RRFK00092, RRFK00176, RRFK00142, RRFK00036, RRFK00242, RRFK00151, RRFK00183, RRFK00060, RRFK00257, RRFK00061, RRFK00074, RRFK00217, RRFK00273, RRFK00171, RRFK00250, RRFK00158, RRFK00220, RRFK00163, RRFK00208, RRFK00279, RRFK00205, RRFK00098, RRFK00288, RRFK00063, RRFK00110, RRFK00072, RRFK00235, RRFK00267, RRFK00077, RRFK00079, RRFK00081, RRFK00182, RRFK00090, RRFK00197, RRFK00214, RRFK00084, RRFK00100, RRFK00245, RRFK00075, RRFK00114, RRFK00260