e.cam Gamma Camera, an emission computed tomography system
Medical device recall Z-0208-2016. Published in FDA’s Enforcement Report on Nov 11, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 11, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 32296 e.cam Gamma Camera systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
32296 e.cam Gamma Camera systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
E.cam Model numbers affected : 4380213, 4380221, 5242826, 5077066, 5077074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7760161, 7761161, 7823920, 7823938, 7823946,…
Every code shown here, 1,996 characters
E.cam Model numbers affected : 4380213, 4380221, 5242826, 5077066, 5077074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7760161, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10520745. This recall applies only to ecam systems that were installed before December 31st 2004. Serial Numbers 7438, 7440, 81010, 1011, 8509, 8510, 1, 1007, 1008, 1010, 1019, 1020, 2001, 2004, 2006, 2007, 2009, 2010, 2014, 2017, 2019, 2022, 2023, 2025, 3002, 3006, 3008, 3010, 3011, 3012, 3013, 3014, 3017, 3021, 3022, 3023, 3024, 3029, 3031, 3034, 4001, 4002, 4004, 4008, 4009, 4010, 4011, 4013, 4014, 4016, 1006, 1009, 1015, 1016, 1020, 1021, 1024, 1025, 1029, 1030, 1031, 1032, 1033, 1041, 1044, 1046, 1051, 1056, 1057, 1063, 1068, 1069, 1070, 1071, 10711, 1074, 1076, 1077, 1079, 1084, 1092, 1095, 1096, 1098, 1100, 1102, 1105, 1106, 1111, 1116, 1117, 1118, 1122, 1123, 1124, 1127, 1130, 1132, 1133, 1134, 1135, 1136, 1137, 1142, 1143, 1146, 1148, 1150, 1151, 1153, 1155, 1157, 1158, 1160, 1161, 1162, 1163, 1165, 1166, 1169, 1172, 1174, 1176, 1180, 1181, 1182, 1184, 1186, 1187, 1188, 1189, 1190, 1191, 1192, 1196, 1197, 1199, 1200, 12009, 1201, 1202, 1205, 1206, 1207, 1208, 121010, 1211, 1234, 126110, 21909, 26011, 31609, 31711, 31827, 41207, 62111, 62310, 7030, 71410, 71411, 7440, 7502, 7582, 8149, 82409, 9, 918073, 1002, 1006, 1009, 1013, 1014, 1015, 1016, 1019, 1020, 1021, 1024, 1029, 1034, 1036, 1037, 1038, 1039, 1046, 1049, 1052, 1056, 1058, 1059, 1062, 1063, 1065, 1067, 1071, 1077, 1080, 1081, 1082, 1083, 1088, 1089, 1094, 1095, 1099, 1101, 1103, 1104, 1105, 1107, 1109, 1110, 1113, 1114, 1116, 1118, 1121, 1129, 1130, 1131, 1135, 1136, 1137, 1138, 1139, 1141, 1142, 1143, 2001, 2004, 2006, 2007, 2008, 2010, 2012, 2013, 2014, 2015, 2017, 2019, 2024, 2026, 2027, 2028, 2030, 2036, 2038, 2039, 2041, 2042, 2045, 2047, 2048, 2050, 2051, 2052, 2055, 2058, 2060, 2065, 2066, 2074, 2075, 2076,…
FDA’s list runs to 14,849 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (nationwide) and countries of: United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, Cameroon, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominica, Ecuador, Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Croatia, Canary Islands, Ireland, Israel, India, Iraq, Iran, Islamic-Republic of, Italy, Jordan, Japan, Korea-Republic of, Kuwait, Lebanon, Sri Lanka, Luxembourg, Latvia, Morocco, Myanmar, Mauritius, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Russian Federation, Saudi Arabia, Sweden, Slovakia, El Salvador, Syrian Arab Republic (Syria), Thailand, Tunisia, Turkey, Taiwan, Republic of China, Ukraine, Uganda, Uzbekistan, and South Africa.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 26, 2015.
- FDA classified it on Nov 4, 2015.
- FDA’s Enforcement Report published it on Nov 11, 2015.
- FDA terminated it on Dec 23, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Hoffman Estates, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 14,849 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.