Envisor, M2540 Diagnostic Ultrasound System
This recall has been terminated (originally issued June 22, 2005).
- Company
- Philips Ultrasound, Inc.
- Recall Initiated
- May 13, 2005
- Posted
- June 22, 2005
- Terminated
- May 9, 2008
- Recall Number
- Z-0923-05
- Quantity
- 194
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
A defect in the software allows incorrect measurement results to be entered into the system's built-in report.
Distribution
Units were distributed nationwide to hospitals and medical centers and internationally.
Lot / Code Info
Part numbers: 453561193003, SW C.O.O. Serial numbers(domestic) 20505841, 20505867, 20505884, 20505885, 20505886, 20505890, 20505898, 20505907, 20505908, 20505913, 20505923, 20505925, 305056015, 30505960, 30505978, 30505980, 30505997. System Base ID (international): US30505949, US20505848, US20505899, US20505900, US30505999, US30506012, US30506013, US30506016, US30506017, US30506014, US30505977, US30505976, US30505984, US30505985, US30505986, US30505975, US30505987, US20505850, US20505849, US20505840, US30505993, US30505992, US20505865, US20505874, US20505872, US20505873, US20505864, US20505868, US20505877, US30505950, US20505838, US20505857, US20505858, US20505901, US20505905, US20505906, US30505965, US20505918, US30505938, US30505939, US30505942, US30505930, US30505988, US30505964, US30505967, US30505973, US20505837, US20505856, US20505879, US20505883, US20505922, US20505924, US20505844, US20505832, US20505847, US20505845, US20505833, US20505846, US20505871, US20505870, US30505958, US30505957, US30505959, US30505946, US20505881, US20505916, US30505937, US20505882, US30505963, US20505914, US20505921, US30505995, US30505996, US30506000, US30506018, US30505991, US30505983, US30505989, US30505990, US20505843, US20505842, US30506001, US20505828, US30505994, US20505829, US30505966, US20505862, US20505861, US20505859, US20505860, US30505981, US30505982, US20505896, US20505895, US30505933, US30505926, US30505929, US30505927, US30505928, US30505932, US20505869, US30505954, US30505952, US30505953, US30505934, US30505935, US30505951, US30505940, US30505941, US30505945, US20505912, US30506005, US30506006, US30506003, US30506008, US30506007, US30506002, US30506004, US30506009, US30506011, US30506010, US30505974, US30505962, US30505972, US20505866, US20505855, US20505834, US20505830, US20505917, US20505888, US20505889, US20505887, US20505878, US20505897, US30505971, US30505970, US30505943, US30505947, US20505903, US20505904, US30505944, US30505979, US20505892, US20505891, US20505893, US20505876, US20505880, US30505936, US30505955, US30505956, US30505948, US30505968, US20505902, US20505894, US30505969, US20505875
Root Cause
Other
Action Taken
On May 13, 2005 the firm mailed a letter to their customers advising of the problem and that a local representative will visit each site to perform a software upgrade.