Philips Ultrasound, Inc. Envisor, M2540 Diagnostic Ultrasound System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Envisor, M2540 Diagnostic Ultrasound System
Brand
Philips Ultrasound, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Philips Ultrasound, Inc. is recalling Envisor, M2540 Diagnostic Ultrasound System due to A defect in the software allows incorrect measurement results to be entered into the system's built-in report.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A defect in the software allows incorrect measurement results to be entered into the system's built-in report.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026