2022 data FDA MAUDE openFDA FDA Class I

Camera, Scintillation (Gamma)

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §892.1100 (Radiology panel).

FDA MAUDE casebook

openFDA event book Camera, Scintillation LIGHT-BOOK · MAUDE

#964 of 1000 · 404 reports · 1992–2022

  • BOOK 404 reports
  • RANK #964 of 1000
  • DEATH 5 death-typed
  • INJ 51 injury-typed
  • MALF 287 malfunction
  • SPAN 1992–2022
  • PEAK 1999: 65
  • PHOTO Coagulator-Cutter

Nearest event-volume peer: Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (0 report gap)

Camera, Scintillation (Gamma) sits #964 of 1000 among tracked device types with 404 MAUDE reports spanning 1992–2022. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Camera, Scintillation carries 12.6% INJURY-coded reports, 17.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 12.6% corpus 30.3% · below corpus mean (-17.7 pp)
  • MALF 71.0% corpus 64.8% · above corpus mean (+6.2 pp)

Lead product-problem code Unintended System Motion is 14% of coded problems · Lead manufacturer PHILIPS MEDICAL SYSTEMS accounts for 100% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Camera, Scintillation in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Camera, Scintillation (Gamma) carries 404 MAUDE reports, ranked #964 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 287 (71.0%)
Injury 51 (12.6%)
Other 50 (12.4%)
11 (2.7%)
Death 5 (1.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

258 (62.2%)
Other 100 (24.1%)
Required Intervention 31 (7.5%)
Death 6 (1.4%)
Hospitalization 6 (1.4%)
R 5 (1.2%)
H 2 (0.5%)
O 2 (0.5%)
S 2 (0.5%)
Life Threatening 2 (0.5%)
Disability 1 (0.2%)

Top Product Problems

Unintended System Motion 49
Component Falling 44
Use of Device Problem 26
Other (for use when an appropriate device code cannot be identified) 25
Computer Software Problem 20
Repair 19
Unknown (for use when the device problem is not known) 18
Unintended Collision 16
Device Issue 14
Material Separation 14
Detachment Of Device Component 13
Image Display Error/Artifact 11
Collapse 10
Noise 10
Sticking 10
Device Displays Incorrect Message 9
Design/structure problem 8
Locking mechanism failure 8
Loose 8
Malfunction 8

Yearly Trend

92
1992: 3
93
1993: 2
94
1994: 15
95
1995: 11
96
1996: 29
97
1997: 48
98
1998: 38
99
1999: 65
00
2000: 52
01
2001: 18
02
2002: 12
03
2003: 15
04
2004: 14
05
2005: 17
06
2006: 12
07
2007: 11
08
2008: 10
09
2009: 8
10
2010: 5
11
2011: 6
12
2012: 1
13
2013: 1
14
2014: 3
15
2015: 4
16
2016: 2
18
2018: 1
22
2022: 1

Reports fell to 1 in 2018, down from an average of 3 in the two years before.

Related Entities for Camera, Scintillation (Gamma)

Top Manufacturers

Event Locations

222 (55.0%)
HOSPITAL 123 (30.4%)
INVALID DATA 30 (7.4%)
NO INFORMATION 9 (2.2%)
UNKNOWN 8 (2.0%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (1.2%)
AMBULATORY SURGICAL FACILITY 2 (0.5%)
OTHER 2 (0.5%)
I 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Camera, Scintillation: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (404 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Disclaimer: MAUDE figures for Camera, Scintillation are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Camera, Scintillation; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.