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    Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 26, 2014

    Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 29, 2026

    Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS Cat. PO11OTASS8, Kit, Trauma Hip A and B, Sterile; (11) Presource PBDS Cat. PO11OTSSP, Kit, Trauma Knee A and B, Sterile; (12) Presource PBDS Cat. PO11THAS13, Kit, Anterior Hip, Sterile; (13) Presource PBDS Cat. PO12AHSUQ, Kit, Anterior Hip, Sterile; (14) Presource PBDS Cat. PO12AHSU7, Kit, Anterior Hip, Sterile; (15) Presource PBDS, Cat. PO18AHEFG, Kit, Anterior Hip, Sterile; (16) Presource PBDS Cat. PO3LHPLM2, Kit, Hip Pinning, Sterile; (17) Presource PBDS Cat. PO3LHPLM3, Kit, Hip Pinning, Sterile; (18) Presource PBDS Cat. PO33AHCRA, Kit, Anterior Hip, Sterile; (19) Presource PBDS Cat. PO56MLGRA, Kit, MC Lower Extremity, Sterile; (20) Presource Spine Pack, Cat. SNECGSPAHB,Sterile; (21) Presource Spine Pack, Cat. SNECGSPAH4, Sterile; (22) Presource Ortho Laminectomy Pack, Cat. SNE12OL89A, Sterile; (23) Presource ACD Pack, Cat. SNE33ACCRD, Sterile; (24) Presource Anterior Fusion Pack, Cat. SNE33AFC18, Sterile; (25) Presource Lumbar Disk Pack, Cat. SNE33LMCAB, Sterile; (26) Presource SDMC Ortho Spine Accessory Pk, Cat. SNE73SAKSD, Sterile; (27) Presource Hip Arthroscopy Pack, Cat. SOPCNHAMSD, Sterile; (28) Presource Anterior Approach Total Hip Pk, Cat. SOPDKAHC12, Sterile; (29) Presource Physician Partner of America, Cat. SOPHFLSHAC, Sterile; (30) Presource MH Hip With Curtain Std Pack, Cat. SOPMHHCM10, Sterile; (31) Presource Back Pack, Cat. SOPOCBPLSD, Sterile; (32) Presource HFHS Ortho Spine Pack, Cat. SOPW1OSHFM, Sterile; (33) Presource PED Extremity Pack, Cat. SOP11PER12, Sterile; (34) Presource Hip Arthroscopy Pack, Cat. SOP12HAGTC, Sterile; (35) Presource OPSC Hip Arthroscopy Pack, Cat. SOP12HAUVE, Sterile; (36) Presource Major Ortho, Cat. SOP12MJHM6, Sterile; (37) Presource Pedi Ortho Spine W Basin Pack, Cat. SOP22PSMRE, Sterile; (38) Presource Lower Extremity Pack 302095, Cat. SOP3LLESGK, Sterile; (39) Presource ORIF Wrist Sturgeon Pack, Cat. SOP30ACSCG, Sterile; (40) Presource Ensemble Pied Cheville 3, Cat. SOP30AKJTF, Sterile; (41) Presource Fracture Pack, Cat. SOP30FRUHE, Sterile; (42) Presource Anterior Total Hip Pack, Cat. SOP30HALHB, Sterile; (43) Presource Hip Pack, Cat. SOP30HPWME, Sterile; (44) Presource Hip Scope Pack, Cat. SOP30HSCHE, Sterile; (45) Presource Ortho Split Pack, Cat. SOP30OSVI8, Sterile; (46) Presource Pack Trauma Uppr Extrmty Civic, Cat. SOP30UPOHD, Sterile; (47) Presource Anterior Hip Pack, Cat. SOP32AHGMH, Sterile; (48) Presource Anterior Tha Pack, Cat. SOP33ANOOI, Sterile; (49), Presource CPT Ortho Custom UH Pack, Cat. SOP33OROUJ, Sterile; (50) Presource CPT Ortho Custom UH Pack, Cat. SOP33OROU5, Sterile; (51) Presource Anterior Hip Pk, Cat. SOP35AHAMG, Sterile; (52) Presource Hip Pack, Cat. SOP41HISP6, Sterile; (53) Presource Spine Tray, Cat. SOP44STHPC, Sterile; (54) Presource Anterior Hip Pack, Cat. SOP5BAHHEE, Sterile; (55) Presource Essentia Anterior Hip Surgi Pk, Cat. SOP5BHSEHD, Sterile; (56) Presource CPT Ortho Custom James Pk, Cat. SOP5CCJOUH, Sterile; (57) Presource Back Part 1, Cat. SOP51BAKOF, Sterile; (58) Presource Back Part 1, Cat. SOP51BAKO9, Sterile; (59) Presource Pack Total Hip Anter Surg WMC, Cat. SOP53APKP4, Sterile; (60) Presource West Hip Anterior Total Pack, Cat. SOP56HAMT8, Sterile; (61) Presource Anterior Hip Pack, Cat. SOP57AHSH5, Sterile; (62) Presource Total Hip Pack, Cat. SOP6VTHPOA, Sterile; (63) Presource ASU Hip Arthroscopy Pack, Cat. S

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023