🔍 RecallPedia

Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

Class I - Dangerous
🏥 Medical Devices Recalled: December 4, 2013 Philips Medical Systems (Cleveland) Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model #882412; Serial #'s:14701, 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710 & 14711. Model #882438; Serial #'s:17002, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 17010, 17011, 17012, 17013, 17014, 17015, 17017, 17018, 17019, 17021, 17022, 17023, 17024, 17025, 17026 & 17028. Model #882470; Serial #'s: 7003, 7004, 7005, 7006, 7008, 7009, 7010, 7011, 7014, 7015, 7017, 7019, 7020, 7021, 7022, 7024, 7025, 7026, 7031, 7034, 7035, 7036, 7039, 7043, 7045, 7049, 7050, 7052, 7053, 7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7074, 7075, 7077, 7080, 7081, 7084, 7085, 7086, 7087, 7089, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7108, 7112, 7114, 7115, 7118, 7120, 7121, 7122, 7123, 7124, 7125, 7128, 7129, 7131, 7135, 7137, 7138, 7139, 7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7166, 7168, 7173, 7174, 7176, 7177, 7181, 7183, 7184, 7185, 7186, 7187, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7200, 7207, 7208, 7210, 7211, 7215, 7216, 7223, 7224, 7226, 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7501, 7503, 7507, 7508, 7511, 7514, 7517, 7518, 7520, 7521, 7523, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7536, 7538, 7540, 7545, 7546, 7554, 7559, 7564, 7566, 7568, 7570, 7573, 7581, 7583, 7584, 7586, 7590, 7591, 7104M, 7106M, 7170M &7582M. Model #882471; Serial #'s: 7007, 7012, 7013, 7016, 7027, 7028, 7029, 7030, 7032, 7037, 7042, 7044, 7048, 7055, 7057, 7059, 7061, 7063, 7065, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152, 7153, 7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178, 7179, 7180, 7182, 7188, 7189, 7190, 7192, 7201, 7202, 7203, 7204, 7205, 7206, 7209, 7212, 7213, 7214, 7217, 7218, 7219, 7221, 7227, 7229, 7231, 7234, 7236, 7238, 7241, 7245, 7251, 7252, 7253, 7254, 7255, 7256, 7257, 7258, 7504, 7506, 7509, 7510, 7512, 7515, 7516, 7519, 7524, 7525, 7535, 7537, 7539, 7542, 7543, 7544, 7548, 7549, 7550, 7552, 7553, 7555, 7556, 7557, 7558, 7560, 7561, 7562, 7563, 7567, 7569, 7572, 7574, 7575, 7577, 7578, 7579, 7585, 7587, 7589 &7592. Model #882473; Serial #'s: 7040, 7048, 7070, 7095, 7111, 7113, 7127, 7130, 7134, 7150, 7151, 7155, 7157, 7162, 7237 & 7249. Model #:882476; Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229 & 9231.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Medical Systems (Cleveland) Inc
Reason for Recall:
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

Product Codes/Lot Numbers:

Model #882412; Serial #'s:14701, 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710 & 14711. Model #882438; Serial #'s:17002, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 17010, 17011, 17012, 17013, 17014, 17015, 17017, 17018, 17019, 17021, 17022, 17023, 17024, 17025, 17026 & 17028. Model #882470; Serial #'s: 7003, 7004, 7005, 7006, 7008, 7009, 7010, 7011, 7014, 7015, 7017, 7019, 7020, 7021, 7022, 7024, 7025, 7026, 7031, 7034, 7035, 7036, 7039, 7043, 7045, 7049, 7050, 7052, 7053, 7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7074, 7075, 7077, 7080, 7081, 7084, 7085, 7086, 7087, 7089, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7108, 7112, 7114, 7115, 7118, 7120, 7121, 7122, 7123, 7124, 7125, 7128, 7129, 7131, 7135, 7137, 7138, 7139, 7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7166, 7168, 7173, 7174, 7176, 7177, 7181, 7183, 7184, 7185, 7186, 7187, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7200, 7207, 7208, 7210, 7211, 7215, 7216, 7223, 7224, 7226, 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7501, 7503, 7507, 7508, 7511, 7514, 7517, 7518, 7520, 7521, 7523, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7536, 7538, 7540, 7545, 7546, 7554, 7559, 7564, 7566, 7568, 7570, 7573, 7581, 7583, 7584, 7586, 7590, 7591, 7104M, 7106M, 7170M &7582M. Model #882471; Serial #'s: 7007, 7012, 7013, 7016, 7027, 7028, 7029, 7030, 7032, 7037, 7042, 7044, 7048, 7055, 7057, 7059, 7061, 7063, 7065, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152, 7153, 7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178, 7179, 7180, 7182, 7188, 7189, 7190, 7192, 7201, 7202, 7203, 7204, 7205, 7206, 7209, 7212, 7213, 7214, 7217, 7218, 7219, 7221, 7227, 7229, 7231, 7234, 7236, 7238, 7241, 7245, 7251, 7252, 7253, 7254, 7255, 7256, 7257, 7258, 7504, 7506, 7509, 7510, 7512, 7515, 7516, 7519, 7524, 7525, 7535, 7537, 7539, 7542, 7543, 7544, 7548, 7549, 7550, 7552, 7553, 7555, 7556, 7557, 7558, 7560, 7561, 7562, 7563, 7567, 7569, 7572, 7574, 7575, 7577, 7578, 7579, 7585, 7587, 7589 &7592. Model #882473; Serial #'s: 7040, 7048, 7070, 7095, 7111, 7113, 7127, 7130, 7134, 7150, 7151, 7155, 7157, 7162, 7237 & 7249. Model #:882476; Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229 & 9231.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0932-2014

Related Recalls

Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

Aug 5, 2025 Other Medical Devices Nationwide View Details →