NT Intera Magnetic Resonance Image System
This recall has been terminated (originally issued September 29, 2004).
- Recall Initiated
- August 20, 2004
- Posted
- September 29, 2004
- Terminated
- February 9, 2006
- Recall Number
- Z-1488-04
- Quantity
- 156 devices
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for patient burn
Distribution
Units distributed to medial facilities and hospitals throughout the U.S.
Lot / Code Info
Part #s 9896 030 09981, 9896 030 10251 Site #s 504531, 104343, 59488, 41391, 37996, 37979, 85119, 26269, 59435, X1281, 504409, 102353, 13606, 103166, 37929, 104392, 103149, 84418, 6947, 63046, 86293, 102978, 103904, 105315, 504866, X0038, 103582, 100745, 101946, 103333, 504412, 13056, 100786, 59428, 103818, 105314, 50430, 104808, 85139, 45016, X0716, X0942, X1272, X1086, X0214, 103324, 101420, 103579, 103847, 6808, 104467, 38652, 103347, 14117, 86335, 68196, 104032, 103417, 103243, 103207, 104102, 52408, 6841, 47029, 41346, 45065, X0164, X1082, 104912, X0083, 104054, 83325, 103911, 101477, 250156, 25958, 104193, 102547, 85172, 104897, 104070, 506190, 103946, 504608, 104340, 100462, 505007, 101595, 104095, 13932, 87527, 38966, 87604, 50336, 86085, 103291, 103592, 103098, 38257, 104532, 101162, 504897, 87018, 104336, X1693, 59637, 103143, 102933, 505021, 103631, 103552, 82678, X1635, X0162, 14065, 103530, 505568, 500034, 250498, 103099, 38438, 76359, 104138, 101561, 101560, 47043, 17394, 105271, X1215, 13057, 250475, 102569, 103770, 86313, X1179, X1523, 504632, 504527, X1412, 104942, 38317, 103101, 26119, 103509, 103544, 85433, 103547, 250122, 102896, 85158, 41342, 86012, 103907, 103909, 101408, 38420
Root Cause
Other
Action Taken
On 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.