Audit every failure-mode label against FDA wording.

Supporting official wording

1. microbial contamination

   Z-0999-2023 · Event 91136

2. contaminated with Burkholderia cepacia

   Z-1182-2021 · Event 87371

3. contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia

   Z-1837-2021 · Event 87976

Contributing exact events

• FDA event 99242
• FDA event 99208
• FDA event 99147
• FDA event 99145
• FDA event 99120
• FDA event 99112
• FDA event 99072
• FDA event 99071

Supporting official wording

1. undeclared desmethyl carbodenafil and undeclared milk

   D-1144-2017 · Event 77768

2. undeclared sildenafil and tadalafil and undeclared milk

   D-0126-2018 · Event 77859

3. undeclared milk

   D-1117-2017 · Event 77375

Contributing exact events

• FDA event 99275
• FDA event 99255
• FDA event 99218
• FDA event 99118
• FDA event 99117
• FDA event 99082
• FDA event 99057
• FDA event 99038

Supporting official wording

1. sterile packaging to be compromised

   Z-2749-2020 · Event 85952

2. sterile packaging to be compromised

   Z-2748-2020 · Event 85952

3. sterile barrier may be compromised

   Z-2221-2024 · Event 94778

Contributing exact events

• FDA event 99217
• FDA event 99216
• FDA event 99204
• FDA event 99114
• FDA event 99032
• FDA event 98976
• FDA event 98915
• FDA event 98897

Supporting official wording

1. Packaging error

   Z-1288-2022 · Event 90273

2. label for affected devices is missing

   Z-1130-2026 · Event 98176

3. mislabeling

   Z-2386-2021 · Event 88388

Contributing exact events

• FDA event 99319
• FDA event 99256
• FDA event 99121
• FDA event 99099
• FDA event 99056
• FDA event 98979
• FDA event 98910
• FDA event 98891

Supporting official wording

1. may not meet the required tensile strength specification

   Z-0531-2026 · Event 97877

2. out-of-specification

   Z-0235-2025 · Event 95432

3. out-of-specification

   Z-0248-2025 · Event 95432

Contributing exact events

• FDA event 99240
• FDA event 99194
• FDA event 99136
• FDA event 99129
• FDA event 99127
• FDA event 99107
• FDA event 99101
• FDA event 99014

Supporting official wording

1. foreign matter

   Z-1019-2022 · Event 89897

2. foreign bodies

   Z-1578-2026 · Event 98464

3. foreign bodies

   Z-1576-2026 · Event 98464

Contributing exact events

• FDA event 99269
• FDA event 99200
• FDA event 99144
• FDA event 99131
• FDA event 99125
• FDA event 99122
• FDA event 99113
• FDA event 99108

Supporting official wording

1. software version V3.0.5, can cause

   Z-0214-2026 · Event 97646

2. Software anomaly that causes a false display of error

   Z-2554-2026 · Event 99064

3. firmware and all previous releases that a screen unlock failure

   Z-2513-2026 · Event 98517

Contributing exact events

• FDA event 99064
• FDA event 99062
• FDA event 99041
• FDA event 98980
• FDA event 98963
• FDA event 98929
• FDA event 98917
• FDA event 98853

Supporting official wording

1. assembly issue

   Z-1473-2026 · Event 98354

2. manufacturing defect

   Z-1907-2025 · Event 96748

3. manufacturing error

   Z-0927-2023 · Event 91331

Contributing exact events

• FDA event 99350
• FDA event 99296
• FDA event 99275
• FDA event 99269
• FDA event 99233
• FDA event 99137
• FDA event 99130
• FDA event 99123

Supporting official wording

1. Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

   Z-0820-2022 · Event 89644

2. There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

   Z-1485-2025 · Event 96375

3. Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

   Z-0821-2022 · Event 89644

Contributing exact events

• FDA event 99294
• FDA event 99292
• FDA event 99265
• FDA event 99239
• FDA event 99237
• FDA event 99231
• FDA event 99224
• FDA event 99223